MAUDE Adverse Event Report: ZIMMER DENTAL 15 DEG TAPER 3.5P,1MM-2MM; ABUTMENT

Model Number	15AT312
Medical Device Problem Codes	Mechanical Problem (1384); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Weight unknown / not provided.Expiration date and unique identifier (udi) number unknown / not provided.Device manufacturer date unknown / not provided.
Event or Problem Description
It was reported that the abutment loosened.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report, b5: describe event or problem, d4: additional device information, g3: date received by manufacturer, g6: type of report, h1: type of reportable event , h2: follow up type, h3: device evaluated by manufacturer, h4: device manufacturer date, h6: adverse event problem, h10: additional narrative.One (1) 15 deg taper 3.5p,1mm-2mm (15at312) was returned for investigation.Visual evaluation of the as returned product identified one abutment, one cover screw and one guide pin.No damage to the drive feature, just slight wear.No damage to the threads.Functional testing with an in-house implant.To recreate the reported events; verified no malfunction.A pre-existing condition noted on the per was unknown bone density type, poor oral hygiene.The reported device was located on tooth # 23 (fdi) and was used for approximately 8 days.Dhr review was completed for the subject lot number (2022051357).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2022051357) for similar events and no other complaint was identified.Review completed utilizing keywords: loosening & damaged drive feature.Based on the available information, and functional testing device malfunction did not occur, and the reported event (loosening) was non-verifiable.However, the reported event (damaged drive feature) was unconfirmed.
Event or Problem Description
It was reported that the abutment that had been placed on patient's mouth on (b)(6) 2022 at 30 ncm.Loosening on (b)(6) 2022.The doctor tried to retighten it on (b)(6) 2022 but it was impossible as the driver couldn't engage correctly the screw head.Doctor reported as a result of the event : gingivectomy.It was not possible to take impressions, patient would have to come back.

• Brand Name: 15 DEG TAPER 3.5P,1MM-2MM
• Common Device Name: ABUTMENT
• 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: 15852532
• Report Number: 0002023141-2022-02930
• Device Sequence Number: 6393069
• Product Code: NHA
• UDI-Device Identifier: 00889024012035
• UDI-Public: (01)00889024012035(17)270607(10)2022051357
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 15AT312
• Device Catalogue Number: 15AT312
• Device Lot Number: 2022051357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2022
• 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: 11/03/2022
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male