MAUDE Adverse Event Report: ZIMMER DENTAL ABUT HEX-LOCK 3.5MM IMP 4 .5 FLARE; DENTAL ABUTMENT

Model Number	HLA3/4
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Pt info: unk.Email address unknown / not provided.Premarket identification k013227.
Event or Problem Description
Doctor reported that abutment constantly falls at tooth site 46.Placement date: (b)(6) 2016.Patient has been rescheduled for new abutment placement.This event refers to capture to the fourth loosening mentioned.
Event or Problem Description
No further event information is available at the time of this report.
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 g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h6: adverse event problem h10: additional narrative one abut hex-lock 3.5mm imp 4.5 flare (hla3/4) for this complaint were not returned after the event occurred ¿ they were used.Therefore, this investigation was conducted while considering that the products were not returned.Device history record (dhr) review for the lots (63503036 & 63316689) 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.Lots were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot numbers (63503036 & 63316689) for similar events (complaint category keywords: fracture: screw loosening) and 4 other complaints were identified.Therefore, based on the available information, device malfunction and the reported loosening event could not be verified as the exact details of event was unknown/nonverifiable.H3 other text : product not returned.

• Brand Name: ABUT HEX-LOCK 3.5MM IMP 4 .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: 12335887
• Report Number: 0002023141-2021-02180
• Device Sequence Number: 19521386
• Product Code: DZE
• UDI-Device Identifier: 00889024015166
• UDI-Public: (01)00889024015166(17)211031(10)63503036
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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: Lay User/Patient
• Device Expiration Date: 10/31/2021
• Device Model Number: HLA3/4
• Device Catalogue Number: HLA3/4
• Device Lot Number: 63503036
• Was Device Available for Evaluation?: No
• 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: 07/28/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2016
• 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
• Patient Age: 46 YR
• Patient Sex: Female