MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,4.1,16,MTX,MG; DENTAL IMPLANT

Model Number	TSVT4B16
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.
Event or Problem Description
It was reported that an unknown abutment will not seat in the implant due to damaged threads needs to rethread the implant requesting the correct tools, abutment information is unknown.Tooth location not reported.
Additional Manufacturer Narrative
The following sections have been updated: b4: date of this report d1: brand name d4: catalog number g3: date received by manufacturer g4: pma/510(k) number g6: checked "follow-up" h2: checked follow-up type h10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
One tapered screw-vent implant (tsvt4b16) and one unknown zimmer biomet abutment were not returned for investigation.Therefore, visual evaluation could not be performed.The investigation was performed using applicable instructions for use, risk files and other available information.Functional testing could not be performed since the products were not returned.No pre-existing conditions were noted.The products were intended for an unknown tooth location.X-ray and picture images were not provided.Appropriate documentation was reviewed.Dhr review for the lot (63630326) 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.However, dhr review could not be performed for the unknown abutment as the lot number was unknown.Complaint history review was performed for the lot (63630326) for similar events and no other complaints about nonconforming events were identified.However, complaint history review could not be performed for the unknown abutment since the lot/item number was unknown.Based on the available information, device malfunction and the reported event could not be verified since the products were not returned.The following sections have been updated: h3 other text : device not returned.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMP,TSV,4.1,16,MTX,MG
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11210631
• Report Number: 0002023141-2021-00133
• Device Sequence Number: 3557200
• Product Code: DZE
• UDI-Device Identifier: 00889024019850
• UDI-Public: (01)00889024019850(17)220531(10)63630326(241)TSVT4B16
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K101977
• 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: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2021

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: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Model Number: TSVT4B16
• Device Catalogue Number: TSVT4B16
• Device Lot Number: 63630326
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 04/23/2021; 04/28/2021
• Initial Report FDA Received Date: 01/21/2021
• Supplement Report FDA Received Date: 04/23/2021; 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention