MAUDE Adverse Event Report: ZIMMER DENTAL; ABUTMENT SCREW

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Patient's weight unknown/ not provided.Device brand name unknown.Device product code unknown.Device item and lot number unknown.Device 510(k) number unknown.Product not returned to manufacturer.

Event Description

It was reported that the unknown abutment screw loosened.It was also reported that the screw was replaced.

Event Description

It was reported that the unknown abutment screw loosened.It was also reported that the screw was replaced.There was not report of patient injury.

Manufacturer Narrative

This report is being submitted to relay additional information.The following sections are being reported: b5: it was reported that the unknown abutment screw loosened.It was also reported that the screw was replaced.There was not report of patient injury.G4: (b)(6) 2019, g7: follow up, h1: malfunction, h2: additional information, h6: method, results, conclusion codes h10: manufacturer narrative the reported device was not received for evaluation.The reported condition of an abutment screw that loosened was not confirmed.A device history record (dhr) review could not be performed as the reported device lot is unknown.Zimmer biomet quality management system has controls in place to ensure the distribution of conforming product within specifications.A complaint history review could not be performed as the reported device item and lot are unknown.A definitive root cause for the reported event could not be determined.Probable causes related to the reported malfunction include: customer error in screw torqueing, abutment assembly and prepping.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Type of Device: ABUTMENT SCREW
• Manufacturer (Section D): ZIMMER DENTAL; 1900 aston avenue; carlsbad CA 92008
• MDR Report Key: 8511657
• MDR Text Key: 141989652
• Report Number: 0002023141-2019-00157
• 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
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 49 YR