MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for STRYKER LEFT IBO BLADE 5100-037-902 manufactured by Stryker Sustainability Solutions.
[181528921]
Tps tip stryker blade broke intraoperatively. The surgeon was informed and exploration of the missing piece was observed and found and retrieved in the patient? S soft tissue in the mouth. Fda safety report id # (b)(4). Fda received date: 02/21/2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093281 |
| MDR Report Key | 9753632 |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-21 |
| Date of Event | 2019-12-24 |
| Date Added to Maude | 2020-02-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER LEFT IBO BLADE |
| Generic Name | BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL |
| Product Code | GFA |
| Date Received | 2020-02-25 |
| Model Number | 5100-037-902 |
| Lot Number | 18213017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-25 |