MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SP 3.7MM 8MM OCTAGON; DENTAL IMPLANT

Catalog Number	SPB8
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier unknown / not provided a4: patient weight unknown / not provided d4: additional device information unknown / not provided d4: unique identifier (udi) number not available d6: implant date unknown / not provided g4: premarket identification: k011245|k002188 h4: device manufacturer date unknown / not provided.
Event or Problem Description
Doctor has received an empty package, without the implant.Procedure completed.
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) spb8, (impl tapered sp 3.7mm 8mm octagon) for evaluation.Visual evaluation of the as returned implant packaging identified it was already opened, and the outer vial's tamper seal / ring was broken.The inner vial and the implant were missing.The coob is non-verifiable as the condition of the packaging / product when received by the customer is unknown / non-verifiable.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 2120004147.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 2120004147 for similar events and no other complaint was identified.Review completed utilizing keywords: incorrect component quantity.Based on the investigation and risk management file review, the most likely root causes determined from the investigation are improper handling of devices/packaging outside of zimvie control.Therefore, based on the available information, a packaging malfunction could not be verified.The reported event/coob was non-verifiable since the condition of the product/packaging when received by the customer was unknown / non-verifiable.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 SP 3.7MM 8MM 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: 19152271
• Report Number: 0002023141-2024-01252
• Device Sequence Number: 8434441
• Product Code: DZE
• UDI-Device Identifier: 00889024017207
• UDI-Public: (01)00889024017207(17)280926(10)2120004147
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082639
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/18/2024

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: Health Professional
• Device Catalogue Number: SPB8
• Device Lot Number: 2120004147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• 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: 04/22/2024
• Supplement Report FDA Received Date: 09/19/2024
• 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: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic