MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V HA 6MM 5.7MM 11.5MM; DENTAL SCREW

Catalog Number	TSV6H11
Medical Device Problem Codes	Fracture (1260); Unintended Movement (3026)
Health Effect - Clinical Codes	Inflammation (1932); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A4: weight unknown / not provided.E1: last/given name unknown / not provided.G4: additional pma/510(k) number ¿ k013227.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the implant at tooth site #30 was removed due to being fractured.Patient also shows signs of grinding wear on crowns.Symptoms as a result of the event: inflammation.
Event or Problem Description
It was reported that the screw for the implant crown at tooth site #30 became loose multiple times.Patient also shows signs of grinding wear on crowns.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data and additional information.Correction: this event is being updated to correct the reported item and description.The following sections are being reported: b3: date of event unknown / not provided b4: date of this report was updated.B5: event description was updated.D1: brand name unknown / not provided d4: catalog and lot number unknown / not provided g3: date received by manufacturer was updated.G4: pma/510(k) number not available g6: type of report was updated.H2: type of follow up was updated.H6: device code was updated to 3026 h10: narrative/data was updated.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This report is being submitted to relay corrected data, additional information and device evaluation.Correction: mw report 0002023141-2024-01846-1 was submitted incorrectly under the implant.This event is for a fractured implant.A new complaint, (b)(4) was created for the loosening event.The following sections are being reported: b4: date of this report was updated.D9: device availability and return date were updated g3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were added: 4109, 4111 and 3331.H6: investigation findings code was added: 3252.H6: investigation conclusions code was added: 4307.H10: narrative/data was updated.Zimvie received the reported implant for evaluation.Visual evaluation was performed.Implant fracture identified at the collar.Dhr review was completed for the subject lot number 63177958.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 63177958 for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was long-term parafunctional habits (e.G., clenching, bruxism, and overloading) of the patient over the implantation period ¿ patient factors.Therefore, based on the available information, device malfunction did occur.Fracture identified at the collar.The reported event is confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
Event or Problem Description
The supplemental mw, 0002023141-2024-01846-1 for the loosened screw was submitted incorrectly under the implant as a correction.This event is for the fractured implant only.A new complaint, (b)(4) was created to submit the screw correctly.

• Brand Name: IMPL TAPERED SCR-V HA 6MM 5.7MM 11.5MM
• Common Device Name: DENTAL 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19460863
• Report Number: 0002023141-2024-01846
• Device Sequence Number: 12755615
• Product Code: DZE
• UDI-Device Identifier: 00889024019461
• UDI-Public: (01)00889024019461(17)201031(10)63177958
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/30/2020
• Device Catalogue Number: TSV6H11
• Device Lot Number: 63177958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 06/11/2024; 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic