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 2014-08-15 for IMPLANT, ENDOSSEOUS, ORTHODONTIC manufactured by Synthes Usa.
[4882860]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that an unidentified dental bone anchor broke during treatment of a patient. No specific injury to the patient was reported. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12257607]
Part numbers 04. 500. 013 (ti oba plate anchor domed design 4 holes) and 04. 500. 016 (ti oba plate anchor domed design 5 holes) were provided. It is unknown which of the two was the complained device. It is unknown if the device was implanted/explanted. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 | 2520274-2014-13161 |
| MDR Report Key | 4013543 |
| Report Source | 01,05,07 |
| Date Received | 2014-08-15 |
| Date of Report | 2014-07-23 |
| Date of Event | 2014-07-16 |
| Date Mfgr Received | 2014-07-23 |
| Date Added to Maude | 2014-08-29 |
| 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 Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | IMPLANT, ENDOSSEOUS, ORTHODONTIC |
| Product Code | OAT |
| Date Received | 2014-08-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-15 |