MAUDE Adverse Event Report: INTEGRA YORK, PA INC. MIRROR - DBL SIDED, SZ 4; M52 - HYGIENE / PERIODONTAL

Catalog Number 67722

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

Customer initially reports mirrors came off.On (b)(6) 2017 doctor reports no harm done.

Manufacturer Narrative

9/5/17 integra investigation completed.Method: failure analysis, device history evaluation.Results: failure analysis cannot be completed due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.Unconfirmed/no return of device for evaluation.Device history evaluation: nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history/corrections: capa (b)(4) issued (b)(6) 2015 for mirrors separating from frame and capa (b)(4) issued (b)(6) 2011.Health hazard evaluation history: (b)(4) dec.2012 due to glass separation and (b)(4) may 2010 for mirrors dislodging from frame.Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation.Product has not been returned for evaluation.

• Brand Name: MIRROR - DBL SIDED, SZ 4
• Type of Device: M52 - HYGIENE / PERIODONTAL
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; 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: 6835667
• MDR Text Key: 84272614
• Report Number: 2523190-2017-00086
• Device Sequence Number: 1
• Product Code: EAX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 67722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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