MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-04-06 for TI OBA PLATE ANCHOR BRACKET DESIGN 4 HOLES 04.500.012 manufactured by Synthes Monument.
[42034313]
(b)(4). Device not implanted or explanted. Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received. (b)(6). 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
[42034314]
Device report from synthes on an event in (b)(6) as follows: it was reported that the 04. 500. 013 broke while being bent by surgeon during surgery. The plate was not over bent. Surgeon used a new plate. Five minutes delay. No adverse event. No patient harm. This complaint involves one part. This report is 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[43736108]
A device history record review was performed for the subject device lot. Supplier: magnum tool company. Release to warehouse date (manufacturing date): apr 2, 2012. The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. No non-conformances were generated during the production of the subject device. The subject device has been received and is currently in the evaluation process. 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
[45340385]
A product investigation was completed: this complaint is confirmed as the returned plate was received in two pieces (plate section with 4 holes is separate from the anchor bracket section). In addition to being sheared in half, the returned plate is bent in several areas. A thickness measurement of 0. 71mm was able to be taken just adjacent to the area of plate breakage using calipers. Per the relevant drawing the thickness is to be 0. 70mm - 0. 80mm. Therefore, the plate thickness measures within specifications. Whether this complaint can be replicated is not applicable as the plate is already broken in two pieces. A visual inspection, device history record (dhr) review, complaint history review, drawing review, and risk assessment review were performed as part of this investigation. No product design issues or discrepancies were observed. Unable to determine a definitive root cause. However, the complaint condition was most likely caused by over-bending. It is not likely that the design of the device contributed to this complaint. The design is adequate for its intended use when used and maintained as recommended, it did not contribute to the complaint condition. The relevant drawing was reviewed during this evaluation. The plate was made from commercially pure grade 4 titanium and anodized per specification. No product design issues or discrepancies were observed. 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 | 2520274-2016-11993 |
| MDR Report Key | 5551932 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-04-06 |
| Date of Report | 2016-03-23 |
| Date of Event | 2016-03-23 |
| Date Mfgr Received | 2016-05-11 |
| Device Manufacturer Date | 2012-04-02 |
| Date Added to Maude | 2016-04-06 |
| 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 MONUMENT |
| Manufacturer Street | 1051 SYNTHES AVE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TI OBA PLATE ANCHOR BRACKET DESIGN 4 HOLES |
| Generic Name | IMPLANT, ENDOSSEOUS, ORTHODONTIC |
| Product Code | OAT |
| Date Received | 2016-04-06 |
| Returned To Mfg | 2016-04-18 |
| Catalog Number | 04.500.012 |
| Lot Number | 6879038 |
| ID Number | (01)07611819371415(10)6879038 |
| 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 MONUMENT |
| Manufacturer Address | 1051 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-06 |