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 |