MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-06-21 for ULTRA DRIVE 6MM PLUG PULLER N/A 423868 manufactured by Biomet Orthopedics.
[21985692]
It was reported that patient underwent a revision procedure utilizing a plug puller on (b)(6) 2012. During the procedure, the plug puller fractured and was left in the patient's bone. No further information was provided to date.
Patient Sequence No: 1, Text Type: D, B5
[22012784]
The user facility is outside of the united states. No medwatch report was received. The appropriate product identification necessary to review manufacturing history was not provided. Device availability - the remaining portion of the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date. In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00895 |
| MDR Report Key | 2625191 |
| Report Source | 01,07 |
| Date Received | 2012-06-21 |
| Date of Report | 2012-05-11 |
| Date of Event | 2012-05-09 |
| Date Mfgr Received | 2012-05-11 |
| Device Manufacturer Date | 2012-05-11 |
| Date Added to Maude | 2012-06-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. ANGELA DICKSON |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743711021 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 EAST 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 | ULTRA DRIVE 6MM PLUG PULLER |
| Generic Name | NERVE CONDUCTION VELOCITY MEASUREMENT DEVICE |
| Product Code | JXE |
| Date Received | 2012-06-21 |
| Model Number | N/A |
| Catalog Number | 423868 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 EAST BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2012-06-21 |