MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-04-08 for TAMP 03.820.144 manufactured by Synthes Gmbh.
[3253886]
It was reported that during a pdc procedure, the surgeon had inserted the implant and was tamping it into the vertebral body with the tamp. The tamp broke in half down toward the interface with the implant. The surgeon was able to retrieve all of the fragments, and selected another tamp to complete the procedure with no further problems.
Patient Sequence No: 1, Text Type: D, B5
[3792842]
This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10594138]
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. The dhr was reviewed and no issues that would have resulted in this complaint were found. The product evaluation visual inspection revealed the tip was broken off the tamp. The device broke at the threaded connection at the base of the tamp shaft. This is the weakest area of the shaft and if it is overloaded, this is where it should break. This shaft likely saw some lateral forces to have it break in this manner, but it is not known exactly how it occurred. The cutter corresponds to the drawing and processes at the time of manufacture. This complaint is deemed invalid from a manufacturing standpoint.
Patient Sequence No: 1, Text Type: N, H10
[11448583]
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. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-10689 |
| MDR Report Key | 3041770 |
| Report Source | 05,07 |
| Date Received | 2013-04-08 |
| Date of Report | 2012-03-19 |
| Date of Event | 2012-03-19 |
| Date Mfgr Received | 2012-03-19 |
| Device Manufacturer Date | 2007-12-10 |
| Date Added to Maude | 2013-06-05 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Manufacturer G1 | SYNTHES GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 CH-4436 |
| Manufacturer City | OBERDORF |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAMP |
| Product Code | HXG |
| Date Received | 2013-04-08 |
| Returned To Mfg | 2012-03-28 |
| Catalog Number | 03.820.144 |
| Lot Number | A7QA49 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 CH-4436 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-08 |