MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-11-13 for TRUE/LOK EXTERNAL FIXATION SYSTEM WIRE 54-1215 manufactured by Orthofix Inc..
[1012639]
Provided information states that wire breakage was detected 26 days after the initial procedure. Patient had a second procedure to replace the broken wires.
Patient Sequence No: 1, Text Type: D, B5
[8164679]
The device was discarded at the user facility, therefore evaluation by the manufacturer is not possible.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 2183449-2008-00011 |
MDR Report Key | 1264642 |
Report Source | 07 |
Date Received | 2008-11-13 |
Date of Report | 2008-11-13 |
Date of Event | 2008-10-20 |
Date Mfgr Received | 2008-10-28 |
Date Added to Maude | 2009-08-07 |
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 | RANDALL WHEELAND, DIRECTOR |
Manufacturer Street | 1720 BRAY CENTRAL DR. |
Manufacturer City | MCKINNEY TX 75069 |
Manufacturer Country | US |
Manufacturer Postal | 75069 |
Manufacturer Phone | 4697422529 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | TRUE/LOK EXTERNAL FIXATION SYSTEM WIRE |
Generic Name | FIXATION WIRE, 1.8MM X 400MM |
Product Code | DZK |
Date Received | 2008-11-13 |
Model Number | 54-1215 |
Catalog Number | 54-1215 |
Lot Number | UNKNOWN |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ORTHOFIX INC. |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2008-11-13 |