MAUDE Adverse Event Report: ZimVie US Corp LLC TSX IMPLANT, 4.1MMD, 13MML; Dental Implant

Catalog Number	TSX41B13
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an implant label issue with customer.Doctor reported that he noticed the seal was slightly peeled off over the implant and cover screw.He chose not to use it for fear that it may not have been sterile.
Event or Problem Description
It was reported that the seal did not appear intact over implant/cover screw after was removed from box.Doctor never actually placed implant due to concerns with packaging.
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.D1: brand name: unknown / provided.D4: additional device information: unknown / not provided.E1: additional initial reporter information: unknown / not provided.G4: premarket identification pma/510(k) #: unknown / not provided.H4: device manufacturer date: unknown / not provided.Since the lot number and device will not be returned, identifying a definitive root cause will not be possible.Should additional information be received which indicated that the device may have caused or contributed to the event, an additional report would be submitted.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b3: date of event b4: date of this report b5: describe event or problem d1: brand name d2: type of the device d4: additional device information d5: operator of device d9: device availability e: initial reporter g3: date received by manufacturer g4: premarket identification g6: type of report h2: follow up type h4: device manufacturer date h6: adverse event problem.

• Brand Name: TSX IMPLANT, 4.1MMD, 13MML
• Common Device Name: Dental Implant
• Manufacturer (Section D): ZimVie US Corp LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZimVie US Corp LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; +1(561)971-3230
• MDR Report Key: 50425667
• Report Number: 0001038806-2026-04467
• Device Sequence Number: 10377811
• Product Code: DZE
• UDI-Device Identifier: 00844868045113
• UDI-Public: (01)00844868045113(17)310122(10)4120005336
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K220978
• 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: Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/15/2026

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: TSX41B13
• Device Lot Number: 4120005336
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/21/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/06/2026
• Supplement Date Received by Manufacturer: 08/06/2026; 09/03/2026
• Initial Report FDA Received Date: 08/25/2026
• Supplement Report FDA Received Date: 08/25/2026; 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2026
• 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 Sex: Unknown