MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-06-02 for TI OBA PLATE ANCHOR DOMED DESIGN 5 HOLES 04.500.016 manufactured by Synthes Elmira.
[5915649]
It was reported that when the patient came in for follow up, the surgeon noted orthodontic bone anchor (oba) plate and screw construct is loose. Surgeon is planning to remove implants on (b)(6) 2015 and replace with new implants. This is report 4 of 16 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[13282079]
Additional narrative: patient information is unknown device is planned to be explanted on (b)(6) 2015, but has not been explanted yet. 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
[27237697]
A product development investigation was performed for the subject device (part number, 04. 500. 016, anchor t-plate, 5-hole, domed head, orthodontic bone anchor system, lot number 7737811). The subject device was returned in good condition. The returned plate has been contoured and cut with minor cosmetic damage which indicates that the plate was once implanted. Due to the nature of the complaint, the complaint condition was unable to be replicated or verified. The cause of the complaint condition could not be determined. A visual inspection and drawing review were performed as part of this investigation. No product design issues or discrepancies were observed. This complaint is unconfirmed. As previously reported, a review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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
[27237698]
Additional information: revision surgery was performed on (b)(6) 2015. Only the hardware which was confirmed to be loose was explanted from the patient. The explanted hardware includes two (2) plates (part number 04. 500. 016), six (6) screws (part number 04. 500. 026. 01) and one screw (part number 04. 500. 024. 01). No complaint is alleged against the remaining hardware.
Patient Sequence No: 1, Text Type: D, B5
[27369523]
A review of the device history record revealed no complaint related anomalies. The device history record shows lot 7737811 of ti oba plate anchor domed design 5 holes was processed through the normal manufacturing and inspection operations with no rework or non-conformances 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 determined the raw material lot 7126842 was accepted with a non-conformance report to address a high surface finish and surface pitting. Lot 7126842 was approved use as is. There are no indications of any potential issues that would contribute to the complaint condition. A deviation was written to approve the use of billets shorter than specification. The deviation was authorized to mitigate out of flatness anomalies. As no product features were affected by this deviation, there are no indications this deviation had any potential impact to the complaint condition. 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
[27458857]
A revision procedure took place on (b)(6) 2015. This part was not one of the explanted devices. (b)(4). 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
[27458858]
Update: it was reported that the patient was being treated with orthodentic bone anchors (oba). During a follow up visit, the surgeon noticed that two (2) oba plates in maxilla were becoming loose. The surgeon brought the patient back to his office where he removed the hardware in maxilla (two plates and six screws) and replaced it with new oba plates and screws. The revision procedure was successfully performed on (b)(6) 2015 with no surgical delay noted. The patient is doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2015-14160 |
| MDR Report Key | 4810996 |
| Report Source | 05,07 |
| Date Received | 2015-06-02 |
| Date of Report | 2015-05-11 |
| Date Mfgr Received | 2015-07-14 |
| Device Manufacturer Date | 2014-09-09 |
| Date Added to Maude | 2015-06-02 |
| 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 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 5 HOLES |
| Generic Name | IMPLANT, ENDOSSEOUS, ORTHODONTIC |
| Product Code | OAT |
| Date Received | 2015-06-02 |
| Catalog Number | 04.500.016 |
| Lot Number | 7737811 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2015-06-02 |