MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-02-19 for ULTRA-DRIVE III CONSOLE N/A 423935 manufactured by Biomet Orthopedics.
[38550502]
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. Date of event - unknown, initial reporter - unknown, manufacture date? Unknown, product location unknown.
Patient Sequence No: 1, Text Type: N, H10
[38550503]
It was reported that a patient underwent an unknown initial procedure on an unknown date. Subsequently, the patient was revised on an unknown date due to unknown reasons. During the revision, the revision system console failed with an error message and a loose spool. No further information has been provided at this time.
Patient Sequence No: 1, Text Type: D, B5
[40741703]
Upon reassessment of the reported event, it was determined to be not reportable. The initial report was forwarded in error and should be voided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2016-00560 |
| MDR Report Key | 5446684 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-02-19 |
| Date of Report | 2016-02-18 |
| Date Mfgr Received | 2016-02-18 |
| Date Added to Maude | 2016-02-19 |
| 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 | ULTRA-DRIVE III CONSOLE |
| Generic Name | DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT |
| Product Code | JXE |
| Date Received | 2016-02-19 |
| Model Number | N/A |
| Catalog Number | 423935 |
| Lot Number | UNKNOWN |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-02-19 |