MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-02-27 for TI OBA PLATE ANCHOR DOMED DESIGN 4 HOLES 04.500.013 manufactured by Synthes Usa.
[5474093]
It was reported that during an orthodontic bone anchor case, one of the bone anchor plates broke during closing. It is not revision surgery. There was no delay in the surgery. No fragment was generated due to breakage of bone anchor during surgery and no additional intervention was required. Patient outcome is unknown. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12950015]
Device broke during insertion; device was not 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. Report was initially submitted on (b)(4) 2015 but the fda site was down. Advised by fda on (b)(4) 2015 to resubmit medwatch. 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 | 2520274-2015-11033 |
| MDR Report Key | 4553116 |
| Report Source | 07 |
| Date Received | 2015-02-27 |
| Date of Report | 2015-02-04 |
| Date Mfgr Received | 2015-02-04 |
| Date Added to Maude | 2015-02-27 |
| 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 |
| Brand Name | TI OBA PLATE ANCHOR DOMED DESIGN 4 HOLES |
| Generic Name | IMPLANT, ENDOSSEOUS, ORTHODONTIC |
| Product Code | OAT |
| Date Received | 2015-02-27 |
| Catalog Number | 04.500.013 |
| 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 | 2015-02-27 |