MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SP 4.8MM 8MM OCTAGON; DENTAL IMPLANT

Catalog Number	SPWB8
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).G4: additional pma/510(k) numbers k011245, k002188.
Event or Problem Description
It was reported that broken cap found during received shipment inspection.We received the shipment on oct 4, 2024.When we checked the goods, we found that the lid of the plastic outer box of one spwb8 (lot#: 2120010665) was not closed, so we further checked the cap of the inner plastic bottle, and then we found that the joints of the cap were broken in several places.
Additional Manufacturer Narrative
Zimvie received one (1) spwb8, (impl tapered sp 4.8mm 8mm octagon) for evaluation.Visual evaluation of the as returned device identified the implant outer box was opened, and the outer vial's tamper seal / ring was broken almost completely.However, the inner vial was seen inside, along with the implant.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 2120010665.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 2120010665 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿packaging other¿ the customer did submit four (4) images for the reported event.Based on the investigation and risk management file review as per rmf rm-00308-pfmea rev.1, the most likely root cause determined from the investigation is mishandling of packaging outside of zimvie control.Therefore, based on the available information, a packaging malfunction did occur.The reported event/coob was non-verifiable since the condition of the product/packaging 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.The following sections have been updated: b4: date of this report.D9: device availability.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: IMPL TAPERED SP 4.8MM 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: 20535506
• Report Number: 0002023141-2024-03420
• Device Sequence Number: 20887729
• Product Code: DZE
• UDI-Device Identifier: 00889024017597
• UDI-Public: (01)00889024017597(17)290226(10)2120010665
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: SPWB8
• Device Lot Number: 2120010665
• 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
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2024
• 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
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic