MAUDE Adverse Event Report: ZIMMER DENTAL SCREW SURGICAL COVER SP O CTAGON IMP 3MM 5.2MM; DENTAL COVER SCREW

Model Number	OPSCL
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported that the cover screw was impossible to place.Doctor could complete the procedure.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One screw surgical cover sp o ctagon imp 3mm 5.2mm (opscl) was returned for investigation.Visual evaluation of the as returned product identified signs of wear/use around the external threads due to usage.Functional testing was performed using an applicable in-house implant.The screw could not be threaded fully into implant.Device history record (dhr) review for the lot (2019102029) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Complaint history review was performed for the reported lot (2019102029) and no other complaints were identified.Therefore, based on the available information and functional testing, device malfunction did occur and the reported event was confirmed.

• Brand Name: SCREW SURGICAL COVER SP O CTAGON IMP 3MM 5.2MM
• Common Device Name: DENTAL COVER SCREW
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11005377
• Report Number: 0002023141-2020-02173
• Device Sequence Number: 3617927
• Product Code: DZE
• UDI-Device Identifier: 00889024015982
• UDI-Public: (01)00889024015982(17)241028(10)2019102029(241)OPSCL-LZ
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K002188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2024
• Device Model Number: OPSCL
• Device Catalogue Number: OPSCL
• Device Lot Number: 2019102029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1