MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-12-31 for manufactured by Synthes Usa.
[4096111]
A hardware removal of synaptic hardware in right posterior pelvis, where patient's sacro iliac screw is located was reported. The original procedure was performed approximately 4 years ago. The hardware was removed due to pain. The products are not available to be returned. This report is for one unknown screw. This is report 2 of 2 for complaint number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11404308]
Device was used for treatment, not diagnosis. Report is for one unknown screw. Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[27258364]
.
Patient Sequence No: 1, Text Type: N, H10
[27258385]
A hardware removal of symptomatic hardware in right posterior pelvis, where patient's sacro iliac screw is located was reported. The original procedure was performed approximately 4 years ago. The hardware was removed due to pain. This is report 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2013-08001 |
| MDR Report Key | 3544757 |
| Report Source | 05,07 |
| Date Received | 2013-12-31 |
| Date of Report | 2013-12-09 |
| Date Mfgr Received | 2014-01-30 |
| Date Added to Maude | 2013-12-31 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANGELA GRAVES |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | MCV |
| Date Received | 2013-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | WEST CHESTER PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-12-31 |