MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-16 for FOREFOOT INTERNAL BRACE IMPLANT AR-1530-CP manufactured by Arthrex, Inc..
[154848551]
When using the forefoot internal brace implant system, a piece of one of the instruments broke off in the pt's foot. X-ray of the foot was done, the piece was unable to be seen in the foot. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5089117 |
| MDR Report Key | 8906408 |
| Date Received | 2019-08-16 |
| Date of Report | 2019-08-14 |
| Date of Event | 2019-08-09 |
| Date Added to Maude | 2019-08-19 |
| 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 |
| 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 | FOREFOOT INTERNAL BRACE IMPLANT |
| Generic Name | PROSTHESIS, TOE, HEMI,PHALANGEAL |
| Product Code | KWD |
| Date Received | 2019-08-16 |
| Model Number | AR-1530-CP |
| Lot Number | 10298681 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-16 |