MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-03-17 for TI OBA PLATE ANCHOR SCREW SELF-DRILLING 6MM 04.500.026.01 manufactured by Synthes Usa.
[40564700]
(b)(4). Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received 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
[40564701]
It was reported that a patient underwent a bone anchored maxillary protraction (bamp) procedure on (b)(6) 2015. During a post-operative, follow-up visit, it was discovered that the patient had developed an infection in the surgical area. The patient underwent revision surgery on (b)(6) 2016. Some of the hardware was removed and re-positioned. New screws were implanted as they were noticed to be loose. Infection was cleared and the patient's outcome was noted as being "good. " this is report 7 of 9 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[41645104]
The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. 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
[44798959]
Device investigation summary - seven (7) intact screws were returned for evaluation. The implants were undamaged and the threads and tips had no discernible issues. No issues were found with the received implants, and the complaint condition of screws loosening was unable to be confirmed. The cause of the complaint condition could not be determined, but it might have been caused by stripping the hole in the bone during insertion. This complaint is unconfirmed. The returned implants are used for plate fixation during craniofacial procedures as part of the orthodontic bone anchor (oba) system used for the orthodontic movement of teeth. Drawings for the devices were reviewed. No drawing issues or discrepancies were noted. The design was determined to be suitable for the intended use when employed and maintained as recommended. A review of the device history records was unable to be performed since a valid lot number was not known for the devices. 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 | 2520274-2016-11709 |
| MDR Report Key | 5507357 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-03-17 |
| Date of Report | 2016-03-04 |
| Date Mfgr Received | 2016-04-18 |
| Date Added to Maude | 2016-03-17 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TI OBA PLATE ANCHOR SCREW SELF-DRILLING 6MM |
| Generic Name | IMPLANT, ENDOSSEOUS, ORTHODONTIC |
| Product Code | OAT |
| Date Received | 2016-03-17 |
| Returned To Mfg | 2016-03-17 |
| Catalog Number | 04.500.026.01 |
| 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 USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-17 |