MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SP 3.7MM 12M M OCTAGON; DENTAL IMPLANT

Catalog Number	SPB12
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when implant was placed at tooth site #36, the surgeon attempted to remove the mount and the implant came with it, they are still attached to each other.No additional appointment required.No patient impact.Surgery was not completed using another device.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier unknown / not provided.A4: patient weight unknown / not provided.G4: premarket identification k011245/k002188.
Additional Manufacturer Narrative
Zimvie complaint number cmp-(b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h6: adverse event problem h10: additional narrative zimvie received one (1) spb12, (impl tapered sp 3.7mm 12m m octagon) for evaluation.Visual evaluation of the as returned devices identified the implant and bundle mount with signs of use.The implant did not disengage/release from the mount as intended during a physical / functional test.This complaint refers to the specific device being investigated for this complaint record.Device history record (dhr) review was completed for the subject lot number 2120004321.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 2120004321 for similar events and no other complaint was identified.Review completed utilizing keywords: does not disengage/release.Based on the investigation and risk management file review, the most likely root causes determined from the investigation are incorrect techniques used during implant placement - customer error.Therefore, based on the available information and functional testing, a device malfunction did occur.The reported event was confirmed with all the available information.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.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 TAPERED SP 3.7MM 12M M OCTAGON
• 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: 19770622
• Report Number: 0002023141-2024-02422
• Device Sequence Number: 12912610
• Product Code: DZE
• UDI-Device Identifier: 00889024017184
• UDI-Public: (01)00889024017184(17)280926(10)2120004321
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K082639
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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: Health Professional
• Device Catalogue Number: SPB12
• Device Lot Number: 2120004321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2024
• 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
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2023
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic