MAUDE Adverse Event Report: INTEGRA YORK, PA INC. UNIVER TOFFLEMIRE TYPE RE; M51 GENERAL DENTRISTRY

Catalog Number 72-34

Device Problems Component Falling (1105); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2015

Event Type  malfunction  

Manufacturer Narrative

The device involved in the reported incident has been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

Customer initially reports screw won't release causing the filling to fall out.On (b)(6) 2015 customer reports tooth was refilled, no real harm to patient.

Manufacturer Narrative

On (b)(6) 2015 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis - there were 2 tofflemire retainers returned, used, showing minimal wear and no unusual markings.The retainers were tested with a matrix band; upon testing the bands held within specification and the screws released as designed.Device history evaluation: nonconforming product report / nonconforming material report history: (b)(4) issued 12/29/2014 and (b)(4) issued 1/28/2014 for incorrect configurations.Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history: scar # (b)(4) issued 1/14/2015 for tofflemire retainers opened and not seating right, made by (b)(4).Health hazard evaluation history: none.Conclusion: the complaint report cannot be confirmed; testing within the defined specification.

• Brand Name: UNIVER TOFFLEMIRE TYPE RE
• Type of Device: M51 GENERAL DENTRISTRY
• Manufacturer (Section D): INTEGRA YORK, PA INC.; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5004174
• MDR Text Key: 24078807
• Report Number: 2523190-2015-00066
• Device Sequence Number: 1
• Product Code: EIC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72-34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15 YR