MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM; DENTAL IMPLANT

Catalog Number	TSVB10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight: unknown / not provided.G4: premarket identification: k011245|k002188.
Event or Problem Description
It was reported a fracture of the upper part of the implant at tooth site 15 observed when the clinical procedure was finished and patient came to the clinic with the implant fractured.The process was completed with another implant.
Event or Problem Description
It was reported a fracture of the upper part of the implant at tooth site 15 observed when the clinical procedure was finished and patient came to the clinic with the implant fractured.The process was completed with another implant.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D1: brand name unknown / not provided.D4: additional device information updated to tsvb10 unknown lot number.D4: unique identifier (udi) number not available.G3: date received by manufacturer.G4: premarket identification k011028/k013227.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: adverse event problem.H10: additional narrative.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) tsvb10, (impl tapered scr-v sbm 3.7mm 3.5mm 10mm), for evaluation.Visual evaluation was performed; a fracture has been identified on the implants collar.A third-party removal tool attached, and was not identified as reported did not contribute to the event.Dhr review and complaint history review by lot number could not be performed, as the lot number associated with the reported product is not available.However, zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.A complaint history review by item number was conducted for the [tsvb10] dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/product holds for the reported product for similar event.Review completed utilizing keywords: dental: functional: fracture: implant.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was clinician selects implant that is unable to resist long-term occlusal loading.Therefore, based on the available information, a device malfunction did occur.The fracture has been identified on the collar.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.

• Brand Name: IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM
• 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: 21110543
• Report Number: 0002023141-2025-00077
• Device Sequence Number: 12941335
• Product Code: DZE
• UDI-Device Identifier: 00889024017207
• UDI-Public: (01)00889024017207(17)221130(10)63778818
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K061410
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2025

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: 11/30/2022
• Device Catalogue Number: TSVB10
• Device Lot Number: 63778818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2024
• 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; Not provided
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/12/2025; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2017
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 65 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic