MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-27 for UNKNOWN_FRO_PRODUCT UNK_FRO manufactured by Stryker Leibinger Freiburg.
[181198667]
Device is not available for evaluation. If additional information is received it will be reported on a supplemental report. The catalog number for this product is unknown at this time and will be updated upon receipt of more information. This is in regard to the plate. Device not available for return.
Patient Sequence No: 1, Text Type: N, H10
[181198668]
It was reported that, post operative, the product plates fractured and turning rod broke through skin on neck.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0008010177-2020-00013 |
| MDR Report Key | 9764757 |
| Report Source | OTHER |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2019-10-23 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-02-27 |
| 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 Country | DE |
| Manufacturer Postal | D-79111 |
| Manufacturer Phone | 76145120 |
| Manufacturer G1 | STRYKER LEIBINGER FREIBURG |
| Manufacturer Street | BOETZINGERSTR. 41 |
| Manufacturer City | FREIBURG D-79111 |
| Manufacturer Country | DE |
| Manufacturer Postal Code | D-79111 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN_FRO_PRODUCT |
| Generic Name | DISTRACTOR |
| Product Code | MQN |
| Date Received | 2020-02-27 |
| Catalog Number | UNK_FRO |
| 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 DE D-79111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |