MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-28 for TBD UNKNOWN manufactured by Rotation Medical, Inc..
[146211444]
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Patient Sequence No: 1, Text Type: N, H10
[146211445]
It was reported that the patient had bursal sided partial thickness tear. The surgeon did not do a primary repair with the anchors, he used regeneten. Three months after the surgery the patient exhibited a lot of pain and heard a popping sound. An mri was performed and it showed a lot of fragments and was? Lit up?. The surgeon decided to wait a couple of months thinking that the issue reported by the patient it was inflammatory and healing. Patient reported several condition related to swelling the doctor did pull some samples for biopsy, awaiting results, 2 surgeries were performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009351468-2019-00100 |
| MDR Report Key | 8645296 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-28 |
| Date of Report | 2019-07-12 |
| Date Mfgr Received | 2019-07-09 |
| Date Added to Maude | 2019-05-28 |
| 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 | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123585706 |
| 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 | TBD |
| Generic Name | MESH, SURGICAL, COLLAGEN, ORTHOPAEDICS, REINFORCEMENT OF TENDON |
| Product Code | OWY |
| Date Received | 2019-05-28 |
| Catalog Number | UNKNOWN |
| Lot 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 | 2019-05-28 |