MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-19 for BIOINDUCTIVE IMPLANT - MEDIUM 2169-2 manufactured by Rotation Medical.
[142607562]
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
[142607563]
It was reported that the patient underwent initial surgery with the bioinductive implant on (b)(6) 2017, and is now presenting with contractive/adhesive capsulitis. The clinical site has deemed this condition "possibly related" to the bioinductive implant. The patient was treated with two shoulder injections (b)(6) 2018 and (b)(6) 2018). Symptoms persisted and the patient is awaiting surgery for capsular release, manipulation under anesthesia, decompression, and debridement. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009351468-2019-00004 |
| MDR Report Key | 8533560 |
| Date Received | 2019-04-19 |
| Date of Report | 2019-04-19 |
| Date of Event | 2019-03-22 |
| Date Mfgr Received | 2019-03-22 |
| Date Added to Maude | 2019-04-19 |
| 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 |
| 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 | 2019-04-19 |
| Catalog Number | 2169-2 |
| 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 | 2019-04-19 |