MAUDE Adverse Event Report: ZIMMER DENTAL 15 DEG TAPER,3.5P 2MM-3MM; DENTAL IMPLANT

Model Number	15AT323
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that dr.Prepared the implantation for edentulous jaw, and found that the package was empty.Dr.Was able to finish with another product.Tooth location not reported.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
The empty packaging for item: 15at323 (15 deg taper, 3.5p 2mm-3mm) was returned for investigation.Visual evaluation of the as returned packaging identified that both inner and outer packaging had already been opened by the customer.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.Patient pre-existing conditions, tooth location, placement duration and x-ray image were irrelevant to this investigation.Picture image was not provided by the customer.Appropriate documentation was reviewed.Dhr review for the lot: (63792183) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.The dhr was further reviewed to verify the packaging process.No malfunction or nonconformance was identified.Complaint history review was performed for the reported lot number: (63792183) for similar events and no other complaint was identified.Based on the available information, device malfunction and the reported event could not be verified since the condition of the products/packaging as received by the customer was unknown/nonverifiable.The following sections have been updated: b4: date of this report.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.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4) this report is being submitted to relay corrected information.This event was assessed in error under the code for a missing implant, however the item associated with this event is an abutment.Therefore, based on the reported information, this does not meet the definition of a reportable event.As a result, the prior submissions for initial report 0002023141-2021-01747 and supplemental report 0002023141-2021-01747-1 are no longer considered reportable by the manufacturer.No further reports will be submitted for this event.The following sections are being reported: b5: description of event was updated b4: date of this report was updated g3: date received by manufacturer was updated g6: type of report was updated h2: type of follow up was updated h10: additional narrative/data was updated if any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
Upon further review, this event was assessed in error under the code for a missing implant, however the item associated with this event is an abutment.Therefore, based on the reported information, this does not meet the definition of a reportable event.

• Brand Name: 15 DEG TAPER,3.5P 2MM-3MM
• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 12146725
• Report Number: 0002023141-2021-01747
• Device Sequence Number: 11726789
• Product Code: NHA
• UDI-Device Identifier: 00889024012042
• UDI-Public: (01)00889024012042(10)63792183(17)220930
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2021

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 Expiration Date: 09/30/2022
• Device Model Number: 15AT323
• Device Catalogue Number: 15AT323
• Device Lot Number: 63792183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 11/15/2021; 11/24/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 11/18/2021; 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2017
• 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