MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for UNKNOWN PROXIMAL SCREW UNK_KIE manufactured by Stryker Trauma Kiel.
[188404961]
Device was not returned. If additional information becomes available, it will be provided in a supplemental report. Device disposition unknown.
Patient Sequence No: 1, Text Type: N, H10
[188404962]
As reported: "proximal screw back out. No replacement device used, only the screw was removed. " additionally reported: "patient reported pain and x-ray shown indicated screw back out. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0009610622-2020-00135 |
| MDR Report Key | 9907912 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-05 |
| 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 | MR. KEVIN SMITH |
| Manufacturer Street | 325 CORPORATE DRIVE |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer Phone | 2018315000 |
| Manufacturer G1 | STRYKER TRAUMA KIEL |
| Manufacturer Street | PROF. KUENTSCHER-STRASSE 1-5 |
| Manufacturer City | SCHOENKIRCHEN/KIEL D-24232 |
| Manufacturer Country | DE |
| Manufacturer Postal Code | D-24232 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN PROXIMAL SCREW |
| Generic Name | IMPLANT |
| Product Code | HWC |
| Date Received | 2020-03-31 |
| Catalog Number | UNK_KIE |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER TRAUMA KIEL |
| Manufacturer Address | PROF. KUENTSCHER-STRASSE 1-5 SCHOENKIRCHEN/KIEL D-24232 DE D-24232 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |