MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-12-03 for BIOINDUCTIVE IMPLANT UNKNOWN manufactured by Rotation Medical, Inc..
[169088806]
It was reported that the patient had partial thickness cuff tear who underwent subacromial decompression distal clavicle excision and bioinductive implant on (b)(6) 2019. Patient with persistent pain was treated with medication with mild temporary relief. A revision surgery performed on (b)(6) 2019 and showed rice bodies. Patient had history of childhood rheumatology and fibromyalgia. The actual patient condition is unknown. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009351468-2019-00118 |
| MDR Report Key | 9405947 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-12-03 |
| Date of Report | 2020-03-06 |
| Date of Event | 2019-11-04 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2019-12-03 |
| 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 | HOLLY TOPPING |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123913905 |
| Manufacturer G1 | ROTATION MEDICAL, INC. |
| Manufacturer Street | 15350 25TH AVE. NO., SUITE 100 |
| Manufacturer City | PLYMOUTH MN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOINDUCTIVE IMPLANT |
| Generic Name | MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON |
| Product Code | OWY |
| Date Received | 2019-12-03 |
| Catalog Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROTATION MEDICAL, INC. |
| Manufacturer Address | 15350 25TH AVE. NO., SUITE 100 PLYMOUTH MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-12-03 |