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 2016-05-04 for TI OBA PLATE ANCHOR DOMED DESIGN 4 HOLES 04.500.013 manufactured by Synthes Elmira.
[44357371]
Exact date plate broke is unknown; reported as (b)(6) 2015. This report is for an unknown orthodontic bone anchor plate/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (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
[44357372]
Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a bone anchor was broken after it was implanted in the patient. The plate was inserted on (b)(6) 2013. The plate broke in (b)(6) 2015 when they put pressure on it during a treatment. Patient age is (b)(6). She is a healthy young girl who has been treated with bone anchors due to adjustment of her teeth. When the plate broke they switched to features on appliances on the teeth instead of bone. They had to change the treatment. The broken plate was left in place until plates from the other side were removed. Bone anchors and all other parts were removed on (b)(6) 2016. This report is for an unknown orthodontic bone anchor plate. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[46223032]
Date of manufacture: march 08, 2013. A review of the device history record revealed no complaint related anomalies. The device history record shows lot 7257189 of ti oba plate anchor domed design 4 holes was processed through the normal manufacturing and inspection operations with no scrap or rework noted. This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition. A review of the raw material device history record(s) determined the raw material lot 6195562 met all specifications. 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
[47410667]
Added concomitant devices based upon investigation summary. Product investigation summary: one (1) orthodont-bone anchor-pl domed design 4h (part 04. 500. 013, lot 7257189) was received for evaluation with complaint category "broken: postoperatively. " this complaint is confirmed as only a portion of the broken plate was received. The plate section with 4 holes was returned, but the anchor section was not. In addition to being sheared in half, the returned plate is bent in several areas. A thickness measurement of 0. 78mm was able to be taken just adjacent to the area of plate breakage using calipers. Per 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. Four (4) unknown screws were also received with this complaint record, but show no evidence of having contributed to the event. A visual inspection, device history record (dhr) review, and drawing review were performed for the returned plate as part of this investigation. No product design issues or discrepancies were observed. The relevant drawing was reviewed during this evaluation. The plate was made from commercially pure grade 4 titanium and anodized. No product design issues or discrepancies were observed. The manufacturer is unable to determine a definitive root cause. However, the complaint condition was most likely caused by excessive strain by patient. It is not likely that the design of the device contributed to this complaint. No new, unique, or different patient harms were identified as a result of this evaluation. 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
| Report Number | 2520274-2016-12508 |
| MDR Report Key | 5630166 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-05-04 |
| Date of Report | 2016-04-18 |
| Date Mfgr Received | 2016-06-10 |
| Device Manufacturer Date | 2013-03-08 |
| Date Added to Maude | 2016-05-04 |
| 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 | TERRY CALLAHAN |
| 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 | 2016-05-04 |
| Returned To Mfg | 2016-05-13 |
| Catalog Number | 04.500.013 |
| Lot Number | 7257189 |
| ID Number | (01)07611819371422(10)7257189 |
| 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 | 2016-05-04 |