MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-04 for MICROFIX QUICKANCHOR 3/0 SUTURE (01)10886705002443 0086 manufactured by Depuy Mitek Inc..
[119362439]
When the surgeon applied the microfix quickanchor implant, it got pulled out. New implant was opened to finish the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5079563 |
| MDR Report Key | 7846448 |
| Date Received | 2018-09-04 |
| Date of Report | 2018-08-30 |
| Date of Event | 2018-08-29 |
| Date Added to Maude | 2018-09-05 |
| 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 | MICROFIX QUICKANCHOR 3/0 SUTURE |
| Generic Name | POLY ABSORBABLE ANCHOR / STAPLE FIXATION BONE |
| Product Code | NOV |
| Date Received | 2018-09-04 |
| Model Number | (01)10886705002443 |
| Catalog Number | 0086 |
| Lot Number | L603942 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK INC. |
| Manufacturer Address | RAYNHAM MA 02787 US 02787 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-04 |