MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-03-11 for TI OBA SCREW ANCHOR 6MM SELF-DRILLING 04.500.006 manufactured by Synthes Usa.
[5485648]
It was reported that an orthodontic bone anchor screw became loose after several weeks of use. The original procedure took place on (b)(6) 2014 when two (2) screws were placed in the mandible. Only one (1) of those screws has come loose. The complainant screw was removed. The surgeon wants to replace it with another screw so that the teeth continue to progress further along with the use of the mandible. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13053069]
Patient identifying information is not available for reporting. Date of screw loosening is unknown. The complainant screw was explanted on an unknown date. It is unknown if the complainant screw will be returned for manufacturer review/investigation. Investigation could not be completed and no conclusion could be drawn as no device was returned. Without a lot number, the device history record review could not be requested. Device 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
[29740159]
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
[29740160]
Per additional information received;. It was reported that right the bone anchor screw became loose because it was not screwed in properly. On (b)(6) 2015 the screw was explanted and a competitor's 9mm screw was placed, on (b)(6) 2015 the surgeon took the competitors screw out and tried to place a screw anchor 10mm self drilling screw but it not fit properly and than implanted a 12 mm intramedullary fixation screw which worked. There were no reports of any surgical delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2015-11701 |
| MDR Report Key | 4591276 |
| Report Source | 05,07 |
| Date Received | 2015-03-11 |
| Date of Report | 2015-03-02 |
| Date Mfgr Received | 2015-03-17 |
| Date Added to Maude | 2015-03-11 |
| 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 USA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TI OBA SCREW ANCHOR 6MM SELF-DRILLING |
| Generic Name | IMPLANT, ENDOSSEOUS, ORTHODONTIC |
| Product Code | OAT |
| Date Received | 2015-03-11 |
| Catalog Number | 04.500.006 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2015-03-11 |