MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,MCOL MG,3.7MM,8MM; DENTAL IMPLANT

Catalog Number	TSVMB8
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier: unknown / not provided.A2: age at time of the event: unknown / not provided.A3: gender: unknown / not provided.A4: patient weight: unknown / not provided.B3: date of event: unknown / not provided.D10: concomitant medical product: tsx37b11 (x10), tsx implant, 3.7mmd, 11.5mml (x10), lot: 1275485 (x10) tsvmb11, imp,tsv,mcol mg,3.7mm,11.5mml, lot: 1270239.D10: therapy date: unknown.
Event or Problem Description
It was reported that the dentist opened 3 new product packages in front of the territory manager they were all 3 with the inner tub cap broken.A total of 12 implants with the inner tube cap broken were reported.
Additional Manufacturer Narrative
Zimvie complaint number cmp-(b)(4).The following fields have been updated: a: patient identifier 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) tsvmb8, (imp,tsv,mcol mg,3.7mm,8mm) for evaluation.A visual evaluation was performed, the reported implants packaging matched the report.The implants outer vials tamper seals were not broken.The outer vials green cap(s) were fractured.The coob is confirmed.Device history record (dhr) review was completed for the subject lot number 1267722.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 1267722 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : packaging : damaged.The customer did submit images for the reported event.The images showed the implant outer vials green cap was cracked.Based on the investigation and according to the capa, the most likely root cause determined from the investigation was external factors (temperature).This is an ongoing issue which is currently being monitored.Non conformance and health hazard evaluation have been opened to further contain affected products, evaluate potential root causes, and consider applicable corrective actions.Therefore, based on the available information, a packaging malfunction did occur.The implants cap was cracked while the caps tamper seal was intact.The reported event/coob was confirmed.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: IMP,TSV,MCOL MG,3.7MM,8MM
• 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: 20805568
• Report Number: 0002023141-2024-03891
• Device Sequence Number: 13086819
• Product Code: DZE
• UDI-Device Identifier: 00889024019768
• UDI-Public: (01)00889024019768(17)280627(10)1267722
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K111889
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2025

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: TSVMB8
• Device Lot Number: 1267722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2024
• 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: 11/28/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT SEE H10 NARRATIVE.
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic