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 2019-11-10 for ARTHRO BIOINDCTIVE 1 MED 2169-2 manufactured by Rotation Medical, Inc..
[166987967]
It was reported that, after a surgery in which a regeneten bioinductive implant was used over a repair made to treat a musculotendinous junction tear of the infraspinatus, the patient had objective stiffness early in the post operative course, starting at 6 weeks and which persisted throughout the post operative period. No signs of systemic infection. Imaging 8 9 months out showed subacromial bursistis and a tear in line with tendon fibers. The patient was taken to the or where the subacromial bursa was aspirated, biopsied (with frozen section) and cultured. The subacromial bursa was dense with significant scarring directly over the implant as well as laterally. A washout was performed with vancomycin. The bioinductive implant had integrated into tendon laterally but had lifted medially, which he repaired with suture and performed a side to side repair of the tendon. There was synovitis in the glenohumeral joint, which was largely affected; this was treated intraoperatively with an intra articular steroid injection. The patient was diagnosed with septic bursitis and treated for 6 weeks with vancomycin. Now, several months later, patient has progressed well and has returned to playing cello, though he is reportedly not fully improved. 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 | 3009351468-2019-00117 |
| MDR Report Key | 9302917 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-11-10 |
| Date of Report | 2019-11-10 |
| Date Mfgr Received | 2019-10-18 |
| Date Added to Maude | 2019-11-10 |
| 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 | 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 | ARTHRO BIOINDCTIVE 1 MED |
| Generic Name | MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON |
| Product Code | OWY |
| Date Received | 2019-11-10 |
| Catalog Number | 2169-2 |
| Lot Number | UNKNOWN |
| 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 AVE. NO., SUITE 100 PLYMOUTH MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-10 |