MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2014-05-12 for ORTHODONT-BONE ANCHOR-PL DOMED DESIGN 5H 04.500.016 manufactured by Synthes Elmira.
[4478460]
Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the plates broke as the surgeon bent the leg of the plate with the anchoring device at the end about 8-10 mm from the anchoring device. The surgeon selected another plate and the surgery continued with no adverse effect. There was no report of patient harm or of a surgical delay. This report is 1 of 2 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11899582]
Device used for treatment, not diagnosis the investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system. A review of the device history records was performed and no complaint related issues were found. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[22341712]
The broken surfaces are homogenous which indicates material conformity as well. No product fault could be detected. It is likely that mechanical loadings were too high during the bending procedure. Too much force or possibly re bending / twisting on a slight angle may have led to these breakages (marks are clearly visible). Titanium implants should never be bent forwards and backwards. The examination of the raw-material testing certificates and the manufacturing papers showed no deviations regarding material analysis, strength and structural stability. The values were in compliance with ao/asif specification and with the international standard. The device history records review revealed that the measurable dimensions of the returned plates were found to be in compliance with the technical drawings and ao/asif specification. The examination of the raw-material testing certificates and the manufacturing papers showed no deviations regarding material analysis, strength and structural stability. The values were in compliance with ao/asif specification and with the international standard. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[34910536]
Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1719045-2014-10194 |
| MDR Report Key | 3806392 |
| Report Source | 01,05,07 |
| Date Received | 2014-05-12 |
| Date of Report | 2014-04-17 |
| Date of Event | 2014-04-17 |
| Date Mfgr Received | 2014-06-03 |
| Device Manufacturer Date | 2013-04-30 |
| Date Added to Maude | 2014-06-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA PLEWS |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES ELMIRA |
| Manufacturer Street | 35 AIRPORT ROAD |
| Manufacturer City | HORSEHEADS NY 14845 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14845 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHODONT-BONE ANCHOR-PL DOMED DESIGN 5H |
| Generic Name | IMPLANT, ENDOSSEOUS, ORTHODONTIC |
| Product Code | OAT |
| Date Received | 2014-05-12 |
| Returned To Mfg | 2014-05-05 |
| Catalog Number | 04.500.016 |
| Lot Number | 7328088 |
| 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 ELMIRA |
| Manufacturer Address | 35 AIRPORT ROAD HORSEHEADS NY 14845 US 14845 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-12 |