MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-09 for TOMOFIX MEDIALE TIBIAKOPFPLATTE, OPERATI 016.000.386 manufactured by Synthes (usa).
[3442916]
It was reported that the chart in the technique guide contained the wrong values for preoperative planning of osteotomies. No further information was provided. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10871422]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. The device listed in this report is used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. Actual event date not known. Device is not distributed in the united states, but is similar to device marketed in the usa. Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-03235 |
| MDR Report Key | 3157844 |
| Report Source | 01,07 |
| Date Received | 2013-06-09 |
| Date of Report | 2011-03-08 |
| Date Mfgr Received | 2011-03-08 |
| Date Added to Maude | 2013-09-04 |
| 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 | T. MCCARRON |
| 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 |
| Brand Name | TOMOFIX MEDIALE TIBIAKOPFPLATTE, OPERATI |
| Product Code | FTY |
| Date Received | 2013-06-09 |
| Catalog Number | 016.000.386 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-09 |