MAUDE Adverse Event Report: ZIMMER DENTAL IMPL SCR-V HA 3.7MM 3.5MM 13MM; DENTAL IMPLANT

Catalog Number	SVH13
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier unknown / not provided.A2: age at time of the event unknown / not provided.D4: additional device information unknown / not provided.G4: premarket identification k011028/k013227.H4: device manufacturer date unknown / not provided.
Event or Problem Description
The doctor reports that hexagon is damaged.Implant was removed.Procedure not completed with other implant.Affected bone type iii and dental position is 13.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) svh13, (impl scr-v ha 3.7mm 3.5mm 13mm) for evaluation.Visual evaluation was performed, the implant had signs of use.Damage to the implant was identified.The implant appears to have been trephined.The implants collar was fractured, likely from the removal process.The implant drive feature was damaged.Dhr review was completed for the subject lot number 63675718.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 63675718 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : damaged drive feature.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was the torque or speed applied during placement/seating exceeds recommended value.Therefore, based on the available information, a device malfunction did occur.The implants drive feature was damaged.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMPL SCR-V HA 3.7MM 3.5MM 13MM
• Common Device Name: DENTAL IMPLANT
• 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: 19836426
• Report Number: 0002023141-2024-02559
• Device Sequence Number: 7816019
• Product Code: DZE
• UDI-Device Identifier: 00889024018099
• UDI-Public: (01)00889024018099(17)220630(10)63675718
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K061410
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2024

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: 06/29/2022
• Device Catalogue Number: SVH13
• Device Lot Number: 63675718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2017
• 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: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic