MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-06-13 for ORTHODONT-BONE ANCHOR SCR SELF-DRILL L8 04.500.008 manufactured by Synthe Usa.
[3553450]
It was reported by the omf surgeon that the oba screw was broken during insertion and the screwdriver with holding sleeve could not hold the screw firmly. It was discovered that one of the holding sleeve plates was smaller than others which may lead to uneven force transmission during insertion. This is report 1of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[10870085]
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 additional evaluation revealed that the screw is broken. Due to the missing lot number it is not possible to trace back the broken screw neither the manufacturing documents can be checked. Because of the damage the dimensions which would be relevant for this breakage cannot be checked anymore. The microscopic investigation shows correct shape compared to the valid drawing. Our complaint statistics does not show any other similar breakages of this article. We suppose that the implant broke due to a mechanical overloading situation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2013-03348 |
| MDR Report Key | 3166945 |
| Report Source | 01,07 |
| Date Received | 2013-06-13 |
| Date of Report | 2012-07-13 |
| Date Mfgr Received | 2012-07-13 |
| Date Added to Maude | 2013-09-10 |
| 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 | 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 | ORTHODONT-BONE ANCHOR SCR SELF-DRILL L8 |
| Product Code | OAT |
| Date Received | 2013-06-13 |
| Catalog Number | 04.500.008 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHE USA |
| Manufacturer Address | WEST CHESTER PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-13 |