MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-22 for 2169-2 manufactured by Rotation Medical, Inc..
[139554185]
Patient underwent arthroscopic repair of glutea tendon with a regeneten patch (bioinductive collagen implant). Patch successfully placed, anchored, and deployment instrument removed. Surgical procedure completed and patient discharged to home the same day. Patient returned for two week follow up with orthopedist at which time imaging was completed and showed a retained foreign body suspected to be in subcutaneous tissue or it band. The patient was returned to the or and the foreign body location was confirmed with fluoroscopy and retrieved. Foreign body identified to be in the subcutaneous tissue between the it band and the skin. The removed foreign body was identified as the spring mechanism of the delivery system for the regenten patch and a small plastic piece attached to it. Fluoroscopy confirmed no further retained foreign body. The patient was discharged to home on the same day. The manufacturer was notified of the event by materials management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8443182 |
| MDR Report Key | 8443182 |
| Date Received | 2019-03-22 |
| Date of Report | 2019-03-14 |
| Date of Event | 2019-01-16 |
| Report Date | 2019-03-14 |
| Date Reported to FDA | 2019-03-14 |
| Date Reported to Mfgr | 2019-03-22 |
| Date Added to Maude | 2019-03-22 |
| Event Key | 0 |
| Report Source Code | User Facility 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 |
| Generic Name | MESH, SURGICAL, COLLAGEN |
| Product Code | OWY |
| Date Received | 2019-03-22 |
| Catalog Number | 2169-2 |
| Lot Number | RC2AN18K4 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROTATION MEDICAL, INC. |
| Manufacturer Address | 15350 25TH AVENUE SUITE 100 PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-22 |