MAUDE Adverse Event Report: ZIMMER DENTAL; ABUTMENT SCREW

Device Problem Separation Failure (2547)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Event date not provided/unknown.Device brand name unknown.Device product code unknown.Device catalog number and lot number not provided/unknown.Device not returned for evaluation.

Event Description

It was reported that an unknown zimmer abutment screw became stuck into the implant.

Manufacturer Narrative

The product was returned for evaluation.

Manufacturer Narrative

One zimmer replacement screw was returned for inspection with a removed abutment.A visual inspection revealed that the screw is confirmed was heavily damaged at the drive feature and no longer functions.The screw could not be properly identified in this condition.The alleged complaint is confirmed.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: instructions for use for zimmer dental implant systems¿ 4894i rev 3-07/09 seating of prosthetic components: internal hex or octagon components - to properly seat these prosthetic components, place the abutment retaining screw through the abutment and place the assembly into the internal bevel at the coronal portion of the implant.Rotate it until the abutment drops into place.The male hex or octagon should seat fully in the female hex or octagon of the implant once the torque wrench has been used to tighten the abutment to 30ncm.A singular cause cannot be identified.

Event Description

It was reported that an unknown zimmer screw became stripped in the abutment and was stuck in the implant.The customer was advised on what removal tools were needed for the removal of the screw.

• Type of Device: ABUTMENT SCREW
• Manufacturer (Section D): ZIMMER DENTAL; 1900 aston avenue; carlsbad CA 92008
• MDR Report Key: 7321598
• MDR Text Key: 101975335
• Report Number: 0001038806-2018-00189
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Date Manufacturer Received: 05/02/2018
• Patient Sequence Number: 1