MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-04-22 for TI OBA PLATE ANCHOR BRACKET DESIGN 5 HOLES 04.500.015 manufactured by Synthes Elmira.
[11097714]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr.
Patient Sequence No: 1, Text Type: N, H10
[17928735]
Hospital account reported during a procedure the surgeon was bending the plate anchor to conform to patient's bone and it broke. The plate was being bent over a tray and not the patient. Surgeon selected a different plate and completed the procedure. This is 1 of 1 reports for this event, complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18054160]
Synthes is submitting this report as a result of remediation activities related to fda warning letter dated february 2012. Device(s) listed in this report is (are) used for treatment, not diagnosis. Any additional information received regarding this event after filing this report shall be filed on a supplemental mdr. A review of the device history records was performed and no complaint related issues were found. The investigation could not be completed; no conclusion could be drawn, as no product was received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003506883-2013-10135 |
| MDR Report Key | 3070250 |
| Report Source | 05,07 |
| Date Received | 2013-04-22 |
| Date of Report | 2011-08-02 |
| Date of Event | 2011-08-02 |
| Date Mfgr Received | 2011-08-02 |
| Device Manufacturer Date | 2009-02-27 |
| Date Added to Maude | 2013-06-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. T. MCCARRON |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES ELMIRA |
| Manufacturer Street | 35 AIRPORT ROAD |
| Manufacturer City | HORSEHEADS NY 14845 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14845 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TI OBA PLATE ANCHOR BRACKET DESIGN 5 HOLES |
| Product Code | OAT |
| Date Received | 2013-04-22 |
| Catalog Number | 04.500.015 |
| Lot Number | 6072250 |
| 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 ELMIRA |
| Manufacturer Address | 35 AIRPORT ROAD HORSEHEADS NY 14845 US 14845 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-22 |