MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-11-02 for ORTHODONT-BONE ANCHOR SCR SELF-DRILL L8 04.500.008S manufactured by Synthes Gmbh.
[15529080]
Note: blank fields on this form indicate information that is unknown, unavailable or unchanged. Device used for treatment and not diagnosis. Review of synthes device history record revealed no complaint related anomalies for this product lot. Our investigation has shown that both screws are indeed broken off. We do suppose, as it was also mentioned dense bone, that the applied mechanical force, beyond its calculated design, has been resulted in the breakage of the tips. The microscopic views of the broken surfaces due not show any anomalies. Note that both screws were analyzed for conformance to print specification, as well as the device history records were researched. No abnormal findings were identified. Placeholder.
Patient Sequence No: 1, Text Type: N, H10
[16623477]
(b)(4): placeholder.
Patient Sequence No: 1, Text Type: N, H10
[21357562]
The manufacturing records were reviewed and no complaint related issues were found. The investigation could not be completed, no conclusion could be drawn, as product is entering the complaint system. The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[21416064]
A device report from (b)(6) indicated a hospital in (b)(6) reported: during a procedure, surgeon was inserting oba screws, two, and they broke leaving the tips in the patient. Both tips were burred out of the patients bone. Surgeon noted region six was very dense bone and it was in an edentulous area. Screws were used as self drilling and no pre drilling was performed. This is 2 of 2 reports for this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2012-01180 |
| MDR Report Key | 2816508 |
| Report Source | 01,07 |
| Date Received | 2012-11-02 |
| Date of Report | 2012-10-04 |
| Date of Event | 2012-10-02 |
| Date Mfgr Received | 2012-12-17 |
| Date Added to Maude | 2012-11-02 |
| 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 | SHERRY LAING |
| 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 | ORTHODONT-BONE ANCHOR SCR SELF-DRILL L8 |
| Generic Name | ORTHODONT-BONE ANCHOR SCREW |
| Product Code | OAT |
| Date Received | 2012-11-02 |
| Returned To Mfg | 2012-10-05 |
| Catalog Number | 04.500.008S |
| Lot Number | 8059671 |
| 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 | 1. Required No Informationntervention | 2012-11-02 |