MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-08-19 for UNKNOWN TISSUE N/A manufactured by Biomet Biologics.
[52561236]
The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. Event is being reported to fda on one medwatch since the limited information available indicates that a revision procedure may occur. Should additional information be received regarding a revision procedure, the complaint will be reassessed and, if warranted, further medwatch reports will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[52561237]
Patient has been indicated for a future revision due to allograft failure. No additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[61912010]
This follow-up report is being filed to correct information.
Patient Sequence No: 1, Text Type: N, H10
[61912011]
Patient has been indicated for a future revision due to allograft failure. However, no revision procedure has been reported to date. No additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2016-03183 |
| MDR Report Key | 5889940 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-08-19 |
| Date of Report | 2016-07-21 |
| Date of Event | 2016-09-29 |
| Date Mfgr Received | 2016-11-10 |
| Date Added to Maude | 2016-08-19 |
| 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 | MS. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN TISSUE |
| Product Code | NUN |
| Date Received | 2016-08-19 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET BIOLOGICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-08-19 |