MAUDE Adverse Event Report: BIOMET 3I CERTAIN® PREFORMANCE® TEMPORARY CYLINDER 4.1MM (HEXED); ABUTMENT

Catalog Number IPFTC41

Device Problems Fracture (1260); Device Damaged by Another Device (2915)

Patient Problem No Information (3190)

Event Date 03/23/2018

Event Type  Injury  

Event Description

It was reported by the doctor that the ipftc41 hex was damaged while torquing.

Manufacturer Narrative

(b)(4).One certain performance temporary cylinder was returned for inspection with an abutment screw and restoration.The cylinder hex showed signs of wear, and no longer has distinct edges.The abutment screw shows significant signs of wear at the drive feature.No device lot number was provided so a device history record review and a complaint history review could not be performed.Appropriate documentation was reviewed and the following information was identified: documents reviewed: product catalog for restorative technologies instres rev e 04/16 information identified: preformance posts indications: single and multiple-unit cement-retained provisional restorations minimum interarch space of 7mm.Maximum angulation of 15° intraoral use limited to 180 days immediate non-occlusal loading of singe-unit provisional restorations multiple-unit restorations will require an evaluation of occlusal forces in lateral and protrusive excursions and masticatory forces to minimize the load on the provisional restorations guided soft-tissue healing of single and multiple-unit restorations of integrated implants.Complaint indicates the temporary post hex was damaged during torquing.The cylinder was functionally tested with a mating implant, and it was determined that the device would not seat in the drive feature.The alleged event was confirmed following inspection of the temporary post.A root cause for this complaint could not be determined.

• Brand Name: CERTAIN® PREFORMANCE® TEMPORARY CYLINDER 4.1MM (HEXED)
• Type of Device: ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7404292
• MDR Text Key: 104897433
• Report Number: 0001038806-2018-00364
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• PMA/PMN Number: PK060291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Catalogue Number: IPFTC41
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR