MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-30 for STRYKER CURETTE 0306-621-000 manufactured by Stryker / Howmedica Osteonics Corp..
[104194329]
During a kyphoplasty procedure, the tip of the stryker curette broke off inside the patient's l5 vertebrae. Stryker rep contacted stryker and they advised physician to cement the vertebral body with the remaining piece of the curette in place due to it being made of nitinol and is bio-compatible. Physician agreed with the stryker recombination and completed the case without further complications. Physician notified the patient that he left a piece of nitinol in the vertebral body of l-5 that will show up on x-ray. Stryker took the remaining curette for further evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076247 |
| MDR Report Key | 7388067 |
| Date Received | 2018-03-30 |
| Date of Report | 2018-03-29 |
| Date of Event | 2018-03-13 |
| Date Added to Maude | 2018-04-02 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | STRYKER CURETTE |
| Generic Name | STRYKER CURETTE |
| Product Code | HTF |
| Date Received | 2018-03-30 |
| Returned To Mfg | 2018-03-13 |
| Model Number | 0306-621-000 |
| Lot Number | 4580552 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER / HOWMEDICA OSTEONICS CORP. |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-30 |