MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-25 for CONDYLAR PLATE FIXATION IMPLANT manufactured by Oberdorf Synthes Produktions Gmbh.
[134091086]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. 510k: this report is for an unknown plate/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. The investigation could not be completed; no conclusion could be drawn. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[134091094]
Device report from synthes reports an event in (b)(6) as follows :this report is being filed after the review of the following journal article: bhatia dn and page rs (2012). "surgical treatment of lateral clavicle fractures associated with complete coracoclavicular ligament disruption: clinico-radiological outcomes of acromioclavicular joint sparing and spanning implants. " international journal of shoulder surgery, volume 6, issue 4, pages 116-120 (india). The purpose of this retrospective study was (1) to analyze the overall and comparative clinico-radiological outcomes (radiographic and ultrasonographic) of surgical treatment of distal clavicle fractures associated with complete coracoclavicular ligament disruption, and (2) to identify and analyze radiographic patterns of fracture and comminution that are associated with this injury. Between 2005 and 2008, a total of 15 patients with acute, isolated, non-comminuted and comminuted fractures of the lateral clavicle who underwent osteosynthesis were included in the study. There were 13 males and 2 females with an average age of 34. 5 years (range, 20 to 57 years). Patients were divided into 2 groups: 10 patients were operated using a joint-spanning implant (group 1) and 5 were operated using a joint-sparing implant technique (group 2). Patients in group 1 were implanted with an unknown synthes clavicle hook plate. Patients in group 2 were implanted with an unknown synthes 2. 4mm locking compression plate (lcp) distal radius plate along with some form of coracoclavicular fixation using a competitor? S sutures/anchors/endobutton devices. Follow-up included clinical evaluation, radiographic evaluation and, ultrasonographic evaluation. Clinical outcomes were measured using constant score (cs), simple shoulder test (sst), and walch acj score (ws). Radiographs and ultrasonography were used to assess the glenohumeral and acromioclavicular joints and the subacromial space. Mean follow-up period is 26. 1 months (range, 12 to 40 months). Complications were reported as follows: group 1 (with clavicle hook plate): 5 patients had acromioclavicular joint signs. 1 patient had rotator cuff signs. 9 patients had a revision with implant removal. 1 patient had nonunion with subsequent fragment resorption. 3 patient had acromioclavicular joint degeneration. All 3 patients had a clinically symptomatic acromioclavicular joint 1 patient had an acromioclavicular subluxation (grade 2). 6 patients had an abnormal bone formation. 1 patient had supraspinatus lesions that included partial articular-side tears seen in ultrasonographic outcomes. 1 patient had supraspinatus lesion with supraspinatus bursal-side degenerative changes seen in ultrasonographic outcomes. 1 patient had an abnormal subacromial bursal "bunching" with arm abduction. 5 patients had subacromial osteolysis and hook migration. 4 of these patients required implant removal. Resolution of the radiographic subacromial osteolytic lesions was observed at final follow-up. 3 patients had signs of progressive implant loosening (plate disengagement). Group 2 (with lcp distal radius plate): 2 patients had acromioclavicular subluxation (grade 1). 1 patient had acromioclavicular subluxation (grade 2. ) 1 patient had an abnormal bone formation. 1 patient had supraspinatus lesions that included partial articular-side tear. 1 patient had an abnormal subacromial bursal "bunching" with arm abduction seen in ultrasonographic outcomes. This report is for two (3) devices- an unknown ao clavicular hook plate, unknown synthes 2. 4mm locking compression plate (lcp) distal radius plate and unknown synthes screws. This report is for one (1) unk - plate. This impacted product captures the reported unknown clavicle hook plate with the following adverse events: positive acromioclavicular joint signs; rotator cuff signs; revision with implant removal; nonunion; acromioclavicular joint degeneration; acromioclavicular subluxation; abnormal bone formation; supraspinatus lesions (partial articular side and bursal side tears); abnormal subacromial bursal "bunching. This is report 1 of 5 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-60266 |
| MDR Report Key | 8277596 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-25 |
| Date of Report | 2019-01-04 |
| Date Mfgr Received | 2019-01-04 |
| Date Added to Maude | 2019-01-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | EIMATTSTRASSE 3 |
| Manufacturer City | OBERDORF 4436 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 4436 |
| Manufacturer Phone | 6103142063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CONDYLAR PLATE FIXATION IMPLANT |
| Product Code | JDP |
| Date Received | 2019-01-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-25 |