MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-01-29 for MANUAL ORTHOPEDIC SURGICAL INSTRUMENT 873-004 manufactured by Medtronic Sofamor Danek Usa, Inc.
[3122416]
It was reported that the guidewire broke during impaction. No patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[10418692]
(b)(6). (b)(4). Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1030489-2013-00274 |
MDR Report Key | 2932748 |
Report Source | 05,07 |
Date Received | 2013-01-29 |
Date of Report | 2012-12-31 |
Date of Event | 2012-12-31 |
Date Mfgr Received | 2012-12-31 |
Device Manufacturer Date | 2012-12-04 |
Date Added to Maude | 2013-04-16 |
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 | HUZEFA MAMOOLA |
Manufacturer Street | 1800 PYRAMID PLACE |
Manufacturer City | MEMPHIS TN 38132 |
Manufacturer Country | US |
Manufacturer Postal | 38132 |
Manufacturer Phone | 9013963133 |
Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
Manufacturer Street | 1800 PYRAMID PLACE |
Manufacturer City | MEMPHIS TN 38132 |
Manufacturer Country | US |
Manufacturer Postal Code | 38132 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT |
Generic Name | CHAIR, SURGICAL, NON-ELECTRICAL |
Product Code | FZK |
Date Received | 2013-01-29 |
Model Number | NA |
Catalog Number | 873-004 |
Lot Number | SW12D277 |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | N |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2013-01-29 |