MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-16 for UN3 SCREWS, SELF-DRILLING, 1.5X4MM, 5/P 56-15904 manufactured by Stryker Leibinger Freiburg.
[145375745]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. Distributor cannot return for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[145375746]
It was reported by the distributor that during the closure of the bone flap, the screw slipped several times before surgeon could completely drive in the screw in. There was no significant delay or patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2019-00018 |
| MDR Report Key | 8617851 |
| Date Received | 2019-05-16 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-02-18 |
| Date Mfgr Received | 2019-05-10 |
| Date Added to Maude | 2019-05-16 |
| 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 | MR. RYLEE KOOLE |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 76145120 |
| Manufacturer G1 | STRYKER LEIBINGER FREIBURG |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Postal Code | D-79111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UN3 SCREWS, SELF-DRILLING, 1.5X4MM, 5/P |
| Generic Name | IMPLANT |
| Product Code | HBW |
| Date Received | 2019-05-16 |
| Catalog Number | 56-15904 |
| Lot Number | 1000297572 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER LEIBINGER FREIBURG |
| Manufacturer Address | BOETZINGERSTR. 41 FREIBURG D-79111 D-79111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-16 |