MAUDE Adverse Event Report: ZIMMER DENTAL ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE; DENTAL ABUTMENT

Model Number	HLA4/5
Medical Device Problem Codes	Fracture (1260); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient weight unknown / not provided.Pma/510k: k013227, k953101.
Event or Problem Description
It was reported that abutment loosened, 7 months after implantation, the patient felt tooth loosening and came to the clinic for re-examination.The abutment loosening was found.The abutment was removed and new abutment was placed.Tooth location # 15.
Additional Manufacturer Narrative
The following sections have been updated: b4: date of this report b5: describe event or problem d9: device availability g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h6: entered evaluation codes h10: added manufacturer narrative.
Event or Problem Description
It was reported that new information received.Clinician confirmed that the patient went to the dental clinic because of the abutment loosen.After check, the doctor finds the abutment broken.
Additional Manufacturer Narrative
One abut hex-lock 4.5mm imp 5.5 flare (hla4/5) with crown and screw was returned for investigation.Visual evaluation of the as returned product identified that abutment fractured at the hex portion.No apparent malfunction with the screw.Functional testing could not be performed for abutment since the product was fractured, but could be performed for screw with in-house mating implant, no issue identified.Pre-existing conditions as noted on the per was type iii (low) bone density.The device was located on tooth site #15 (universal) for approximately 7 months.X-ray and picture images were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (2019050217).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review by lot number (2019050217) was performed for similar event descriptions and no other complaints identified.Based on the available information, device malfunction (fracture abutment) did occur and the reported event was confirmed.However, other reported event loosening was non-verifiable with the information available.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE
• 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: 12450855
• Report Number: 0002023141-2021-02508
• Device Sequence Number: 3536708
• Product Code: DZE
• UDI-Device Identifier: 00889024015210
• UDI-Public: (01)00889024015210(17)240507(10)2019050217
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K011028
• 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): 02/08/2022

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: Lay User/Patient
• Device Expiration Date: 05/07/2024
• Device Model Number: HLA4/5
• Device Catalogue Number: HLA4/5
• Device Lot Number: 2019050217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/20/2021
• Supplement Date Received by Manufacturer: 10/13/2021; 02/04/2022
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 10/21/2021; 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male