MAUDE Adverse Event Report: SYNTHES ELMIRA TI OBA PLATE ANCHOR DOMED DESIGN 4 HOLES; IMPLANT, ENDOSSEOUS, ORTHODONTIC

Catalog Number 04.500.013

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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).

Manufacturer Narrative

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.

Manufacturer Narrative

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.

• Brand Name: TI OBA PLATE ANCHOR DOMED DESIGN 4 HOLES
• Type of Device: IMPLANT, ENDOSSEOUS, ORTHODONTIC
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5299457
• MDR Text Key: 33582622
• Report Number: 2520274-2015-17886
• Device Sequence Number: 1
• Product Code: OAT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK093299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.500.013
• Device Lot Number: 7798054
• Other Device ID Number: (01)10887587016528(10)7798054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR