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

Model Number	15AT312
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Weight unknown / not provided.
Event or Problem Description
It was reported that abutments fractured and implants were removed.Patient would have to return to place new implants.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
Doctor reported that abutment screws fractured and implants were removed.Patient would have to return to place new implants.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: d9: device available for evaluation change ¿no' to 'yes.' h3: device evaluated by manufacturer: change ¿no' to 'yes.' two abutment and 2 implants were returned for investigation.Visual evaluation of the as returned products identified that the abutments were severely fractured and damaged on top of the implants.Additionally, screw fragments were identified inside the abutments ¿ confirming that the retaining screws (bundled) functional testing could not be performed due to the nature of the devices and events.Pre-existing condition noted on the per was 'high bone density ¿ type i'.The reported devices had been placed on tooth # 13 & 23 (fdi) for approximately 2 years.X-ray & picture evaluation: x-ray or picture images were not provided.Review of appropriate documentation: documents reviewed: instructions for use - tapered screw-vent and trabecular metal implants, ifu4869 rev 9-10/19.Instructions for use ¿ prosthetics for zimmer dental implant systems ¿ ifu4894 rev 6 ¿ 08/19.Information identified: contraindications & precautions.Per the applicable ifu, patient factors such as severe bruxism, clenching, and overloading, may cause component fracture.Dhr review: dhr review for the lot (2019070653) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.However, dhr could not be reviewed for the implant (tsvb11).Complaint history review: complaint history review was performed for the reported lot number (2019070653) for similar events (complaint category keywords: functional: fracture & fracture: screw) and 3 other complaints were identified under (b)(4).A complaint history review by item number was conducted for the (tsvb11) dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product for similar events (complaint category keyword: fracture & fracture: screw).Post market trending review: august post market trending was reviewed and there were no actionable events or corrective actions for the reported events or products.Therefore, based on the available information, device malfunction did occur, and the reported events were confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 15 DEG TAPER 3.5P,1MM-2MM
• Common Device Name: DENTAL 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: 14432929
• Report Number: 0002023141-2022-01213
• Device Sequence Number: 5151154
• Product Code: NHA
• UDI-Device Identifier: 00889024012035
• UDI-Public: (01)00889024012035(17)240712(10)2019070653
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/24/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/12/2024
• Device Model Number: 15AT312
• Device Catalogue Number: 15AT312
• Device Lot Number: 2019070653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 09/22/2022; 10/21/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 10/05/2022; 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2019
• 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: 70 YR
• Patient Sex: Male