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 2014-11-14 for IMPLANT, ENDOSSEOUS, ORTHODONTIC manufactured by Synthes Usa.
[4987457]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a patient had four bone anchors removed. Two of the bone anchors were non-synthes bone anchors. The non-synthes bone anchors were removed easily. The two synthes bone anchors were covered by bone growth. The surgeon had to take a drill to remove the growth; the slot was damaged and they could not take the screw out. The bone anchors were taken out in many pieces and they had to give up taking the synthes screws out. There was a thirty minutes delay in the procedure. This report is for two unknown orthodontic bone anchor systems. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12518337]
Unknown date in 2014. This report is for two unknown orthodontic bone anchor systems/unknown lots. Implant/explant date: unknown. (b)(6). 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 | 2520274-2014-14747 |
| MDR Report Key | 4251431 |
| Report Source | 01,05,07 |
| Date Received | 2014-11-14 |
| Date of Report | 2014-03-01 |
| Date Mfgr Received | 2014-03-01 |
| Date Added to Maude | 2014-11-14 |
| 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 | 2014-11-14 |
| 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 | 2014-11-14 |