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 2015-12-15 for TI OBA PLATE ANCHOR DOMED DESIGN 4 HOLES 04.500.013 manufactured by Synthes Elmira.
[33582622]
Device was used for treatment, not diagnosis. Unknown when device malfunctioned. (b)(4). Device is expected to be returned for manufacturer review/investigation, but has yet to be received. Subject device has not been received. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[33582623]
It was reported that a surgeon performed a bone-anchored maxillary protraction (bamp) procedure and implanted orthodontic bone anchor (oba) implants. The patient came in for follow-up approximately one month ago. The surgeon noticed one of the oba implants was loose. The surgeon removed loose hardware on (b)(6) 2015 and put a new plate in. The patient is doing well. No surgical delay reported. This report is 4 of 4 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[35114225]
Lot number provided by reporter. Date returned to manufacturer. Subject device has been received and is currently in the evaluation process. Investigation is ongoing; 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
[36503916]
Product manufacture date: november 5, 2014. A review of the plate device history record (dhr) revealed no complaint related anomalies. The (dhr) shows this lot of titanium oba plate anchor domed - 4 hole was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted. This order met all dimensional and visual criteria at the time of release with no issues documented during its manufacture that would contribute to this complaint condition a product investigation was completed: the following device(s) was received: anchor t-plate, 4 hole, domed head, orthodontic bone anchor system (part 04. 500. 013, lot 7798054) and 1. 55mm midface self-drilling screw (part 04. 500. 026. 01, lot unknown, quantity: 3). The returned devices are in good condition. Both returned plates have been contoured and cut, with minor cosmetic damage which indicates that the plates were once implanted. The returned screws are in good condition with no functional damage and only minor marring around the hex drive. Due to the nature of the complaint, the complaint condition was unable to be replicated or verified. A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation. During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition. A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation. No product design issues or discrepancies were observed. This complaint is unconfirmed. The relevant drawings for the device(s) 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. Proper use and maintenance for the device(s) are addressed in the technique guide. The root cause of the complaint condition is unknown. No manufacturing or design issues were noted during the investigation. The design determined to be adequate for its intended use when used and maintained as recommended 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 | 2520274-2015-17886 |
| MDR Report Key | 5299457 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-12-15 |
| Date of Report | 2015-11-24 |
| Date Mfgr Received | 2016-01-11 |
| Device Manufacturer Date | 2014-11-05 |
| Date Added to Maude | 2015-12-15 |
| 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 |
| Manufacturer G1 | SYNTHES ELMIRA |
| Manufacturer Street | 35 AIRPORT ROAD |
| Manufacturer City | HORSEHEADS NY 14845 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14845 |
| 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 | 2015-12-15 |
| Returned To Mfg | 2015-12-15 |
| Catalog Number | 04.500.013 |
| Lot Number | 7798054 |
| ID Number | (01)10887587016528(10)7798054 |
| 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 ELMIRA |
| Manufacturer Address | 35 AIRPORT ROAD HORSEHEADS NY 14845 US 14845 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-15 |