MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-11-16 for DHS?/DCS? ONE-STEP LAG SCREW 12.7MM THREAD/95MM 280.295 manufactured by Synthes Elmira.
[92197374]
Additional product code: ktt. Udi: (b)(4). Lot number unknown. Explant is scheduled for (b)(6) 2018. Complainant part is not expected to be returned for manufacturer review/investigation. 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. 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.
Patient Sequence No: 1, Text Type: N, H10
[92197375]
It was reported that a revision is scheduled for (b)(6) 2018 due to malunion of the right femur. The original procedure to repair a pertrochanteric right hip fracture with a dynamic hip screw (dhs) construct was performed on (b)(6) 2011. Subsequently, the malunion was discovered. Device related malfunction is not reported. This report is for one (1) dhs/dcs one-step lag screw 12. 7 mm thread 95 mm. This is report 2 of 7 for com-(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003506883-2017-10265 |
| MDR Report Key | 7037061 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-16 |
| Date of Report | 2017-10-24 |
| Date Mfgr Received | 2018-01-15 |
| Date Added to Maude | 2017-11-16 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES ELMIRA |
| Manufacturer Street | 35 AIRPORT ROAD |
| Manufacturer City | HORSEHEADS NY 14845 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14845 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DHS?/DCS? ONE-STEP LAG SCREW 12.7MM THREAD/95MM |
| Generic Name | APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR. |
| Product Code | JDO |
| Date Received | 2017-11-16 |
| Catalog Number | 280.295 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES ELMIRA |
| Manufacturer Address | 35 AIRPORT ROAD HORSEHEADS NY 14845 US 14845 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-16 |