MAUDE Adverse Event Report: ZIMMER DENTAL TSV TITANIUM ASC SCREW; ABUTMENT SCREW

Model Number	MHLASC
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the abutment was fully seated and out of contact but the screw became loose several days after being placed.
Event or Problem Description
There is no update to the original complaint description provided.
Additional Manufacturer Narrative
One tsv titanium asc screw (mhlasc) was returned for investigation.Visual evaluation of the as returned product identified signs of wear/use but no apparent signs of malfunction.Functional testing was performed using an applicable in-house mating device.The devices were able to assemble as normal (file: functional test).No pre-existing conditions were noted on the per.The device had been placed on an unknown tooth location for an unknown period of time.X-ray & picture evaluation: x-ray or picture images were not provided.Review of appropriate documentation: documents reviewed: tsv bellatek express and bellatek flex (p-texpflex) rev b, april 2021.Information identified: precautions &.Per the applicable ifu, it is stated that improper technique could cause screw loosening.Dhr review: dhr review for the lot (2020050337) 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.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (2020050337) for similar events (complaint category keywords: functional: loosening) and no other complaint was identified.Post market trending review: november post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did not occur.However, the reported event could not be verified as the exact details of event were nonverifiable.

• Brand Name: TSV TITANIUM ASC SCREW
• Common Device Name: ABUTMENT SCREW
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 12414068
• Report Number: 0002023141-2021-02420
• Device Sequence Number: 4687154
• Product Code: NHA
• UDI-Device Identifier: 00844868044789
• UDI-Public: (01)00844868044789(17)250701(10)2020050337
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192522
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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: Lay User/Patient
• Device Expiration Date: 07/01/2025
• Device Model Number: MHLASC
• Device Catalogue Number: MHLASC
• Device Lot Number: 2020050337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose