MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2020-03-31 for UNK - SCREWS: CANNULATED manufactured by Oberdorf Synthes Produktions Gmbh.
[188405718]
Multiple patient involved. Implantation date unknown. This report is for an unk - screws: cannulated/unknown lot. Part and lot numbers are unknown; udi number is unknown. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. (b)(4). 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
[188405719]
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: wong, t. C. , yip, t. H. , and wu, w. C. (2005), carpal ligament injuries with acute scaphoid fractures? A combined wrist injury, journal of hand surgery, vol. 3b, number4, pages 415-418 (china). We have performed a prospective cohort study to determine the incidence and the clinical significance of carpal ligament and tfcc injuries in association with acute scaphoid fractures. From july 1996 to december 2002, a total of 52 patients (48 males and 4 females) with a mean age of 29 (range 11? 76) years were included in the study. Twenty-six patients underwent scaphoid fracture fixation with a 3. 5mm ao/asif (matheys medical limited, bettlach, switzerland) cannulated screw and the remaining patients underwent fixation with acutrak (acumed llc, hillsboro o, or, usa) screws (standard or mini-screw). The following complications were reported as follows: (b)(6)-year-old male patient had nonunion. (b)(6)-year-old male patient had delayed union. 2 patents developed nonunion. 2 patients had delayed union. 4 patients achieved fair results and 3 had poor results. One of these had no persistent pain and the other two only had mild pain. This report is for a 3. 5mm ao/asif (matheys medical limited, bettlach, switzerland) cannulated screw. This is report 1 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-02462 |
| MDR Report Key | 9906656 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-31 |
| 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 | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK - SCREWS: CANNULATED |
| Generic Name | PLATE,FIXATION,BONE |
| Product Code | HWC |
| Date Received | 2020-03-31 |
| 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 | 2020-03-31 |