MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-24 for 6.25MM VS PLATE 4-HOLE LEFT NI 10062P manufactured by Biomet Trauma.
[71166477]
Cmp-(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[71166478]
It was reporeted while the surgeon was bending the plate during a procedure, it fractured. The surgery was completed successfully with an alternative plate. No fractured pieces fell into the patient and no adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
[74392355]
This follow-up report is being submitted to relay additional information. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2017-02049 |
| MDR Report Key | 6432649 |
| Date Received | 2017-03-24 |
| Date of Report | 2017-12-29 |
| Date of Event | 2017-02-15 |
| Date Mfgr Received | 2017-12-28 |
| Device Manufacturer Date | 2004-05-24 |
| Date Added to Maude | 2017-03-24 |
| 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. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| 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 | 6.25MM VS PLATE 4-HOLE LEFT |
| Generic Name | PLATE, FIXATION |
| Product Code | NDF |
| Date Received | 2017-03-24 |
| Returned To Mfg | 2017-04-14 |
| Model Number | NI |
| Catalog Number | 10062P |
| Lot Number | 949097 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET TRAUMA |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-24 |