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
Zimmerbiomet complaint number (b)(4).Patient identifier: unknown / not provided.Age and date of birth: unknown / not provided.Patient sex: unknown / not provided.Weight: unknown / not provided.Date of event: unknown / not provided.Initial reporter name and address: last unknown / not provided.
Event or Problem Description
It was reported that the abutment screw loosened.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The reported device was not returned for investigation.Since products have not been returned, visual and functional inspection could not be performed.No pre-existing conditions were noted on the product experience report (per).The device had been placed on a tooth location #unk for an unknown duration of time.X-ray or picture was not provided.A device history record (dhr)review was performed and no related deviations or nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no additional related complaints for this product lot.Complainant reported that the abutment screw became loosened.The reported complaint could not be verified.A definitive root cause for this complaint could not be determined.

• 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: 12383539
• Report Number: 0002023141-2021-02344
• Device Sequence Number: 3602435
• Product Code: NHA
• UDI-Device Identifier: 00844868044789
• UDI-Public: (01)00844868044789(17)250428(10)2020040228
• 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): 01/31/2022

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: 04/28/2025
• Device Model Number: MHLASC
• Device Catalogue Number: MHLASC
• Device Lot Number: 2020040228
• Was Device Available for Evaluation?: No
• 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: 01/31/2022
• Initial Report FDA Received Date: 08/30/2021
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown