MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-12 for BIOINDUCTIVE IMPLANT - MEDIUM 2169-2 manufactured by Rotation Medical.
[139078766]
Investigation narrative: additional information has been requested from the complainant regarding this incident and the investigation is currently ongoing.
Patient Sequence No: 1, Text Type: N, H10
[139078767]
It was reported that during an arthroscopic rotator cuff repair, the surgeon deployed the regeneten patch implant into the shoulder and in doing so he "lost" the implant. Implant could not be located and is presumed to be still in the patient. A back-up device was available to complete the procedure however, the incident resulted in a surgical delay greater than 30 minutes. No patient injury or other complications were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009351468-2019-00003 |
| MDR Report Key | 8333849 |
| Date Received | 2019-02-12 |
| Date of Report | 2019-02-12 |
| Date of Event | 2019-01-22 |
| Date Mfgr Received | 2019-01-23 |
| Date Added to Maude | 2019-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. GARRETT AHLBORG |
| Manufacturer Street | 15350 25TH AVENUE NORTH SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7637467531 |
| Manufacturer G1 | ROTATION MEDICAL |
| Manufacturer Street | 15350 25TH AVENUE NORTH SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIOINDUCTIVE IMPLANT - MEDIUM |
| Generic Name | MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON |
| Product Code | OWY |
| Date Received | 2019-02-12 |
| Catalog Number | 2169-2 |
| Lot Number | RC2AN18M7 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROTATION MEDICAL |
| Manufacturer Address | 15350 25TH AVENUE NORTH SUITE 100 PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-12 |