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.
[134199947]
This report is for an unknown plates: 3. 5 mm lcp clavicle hook 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, as no product was received. Investigation summary - product was not returned. 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, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[134199948]
This report is being filed after the review of the following journal article: erdle, b. Et al (2017), comparative analysis of locking plate versus hook plate osteosynthesis of neer type iib lateral clavicle fractures, archives of orthopaedic and trauma surgery, vol. 137(5), pages 651-662 (germany). This retrospective, comparative cohort study aims to analyze and compare radiological results, functional outcomes and complications of locking plate osteosynthesis (lpo) versus hook plate osteosynthesis (hpo). For the last 12 years, a total of 32 patients (28 male and 4 female) underwent operative treatment for acute lateral clavicle fractures. Of these patients, 19 patients with a mean age 44. 3? 14. 9 years were treated with 3. 5 mm lcp clavicular hook plate (depuy synthes, west chester, usa) while 13 patients with a mean age of 43. 7? 13. 7 were treated with 3. 5 mm locking compression t-plate (depuy synthes) respectively for (7) patients and 2. 7/3. 5 mm locking compression superior lateral clavicle plate respectively for (6) patients. Standardized radiographs were routinely performed postoperatively, after 3, 4. 5, 6, 12 months and then annually as needed. Mean follow-up period was 54. 2 months (range, 25. 2? 111. 4 months. The following complications were reported as follow under hpo: a (b)(6) years-old at follow-up obtained a satisfactory outcome. This patient showed a symptomatic subacromial impingement syndrome with a mildly positive starter test. 1 patient with a fair result suffered from symptomatic non-union of the lateral clavicle following hook plate osteosynthesis. 2 patients had delayed union. 1 patient had peri-implant fracture 6 weeks after surgery at routine follow-up examination without any history of trauma. 5 patients had acromial osteolysis at follow-up. 8 patients had posttraumatic acj arthrosis. Of these patients 1 showed mild clinical symptoms and did not require secondary surgery. The following complications were reported as follow under lpo: the article did not specify which of the 3. 5 mm lcp t-plate or 2. 7/3. 5 mm lcp superior lateral clavicle plate had caused the complications. 3 cases of lpo implants were removed after a mean time-period of 12. 5 months on explicit patients request due to a subjective sense of local irritation. 3 patients had delayed union. 1 patient had posttraumatic acj arthrosis. This ip captures the 2. 7/3. 5 mm lcp superior lateral clavicle plate. This report is for an unknown synthes 3. 5 mm lcp clavicular hook plate, unknown synthes 3. 5 mm locking compression t-plate and unknown synthes 2. 7/3. 5 mm locking compression superior lateral clavicle plate. This is report 3 of 4 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2019-60357 |
| MDR Report Key | 8278493 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-25 |
| Date of Report | 2019-01-07 |
| Date of Event | 2017-03-20 |
| Date Mfgr Received | 2019-01-07 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |