MAUDE Adverse Event Report: ZIMMER DENTAL; SCREW

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported a unknown zimmer loosening screw that occurred two years ago.Doctor replaced the screw with a new one and no more loosening has been reported until this time.

Manufacturer Narrative

Additional information received through investigation report identified the unknown zimmer screw to be iunihg.Upon reassessment of the reported event, it was determined that this mdr has not been filled under the correct mfr number.Therefore, this event is being reported under (b)(4).No further medwatch reports will be submitted.For additional information please refer to mfr (b)(4).

Event Description

No further event information available at the time of this report.

• Type of Device: SCREW
• Manufacturer (Section D): ZIMMER DENTAL; 1900 aston avenue; carlsbad CA 92008
• MDR Report Key: 8652223
• MDR Text Key: 146658645
• Report Number: 0002023141-2019-00231
• 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: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1