MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 4.5X5.5, 3MM; DENTAL ABUTMENT

Model Number	HC453
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of the event unknown / not provided.
Event or Problem Description
The doctor reported that the two heal collars does not screw.No injury to patient, and no need for surgical intervention.
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).One heal collar 4.5x5.5, 3mm (hc453) and one heal collar 4.5x5.5, 5mm (hc455) were returned for investigation.Visual evaluation of the as returned products identified some signs of use and but no apparent malfunction identified.Functional testing to recreate the reported event could be performed by using in-house compatible implant and the healing collars threaded as intended.Device history record (dhr) review was completed for the subject lot number 63542002 and 63560494.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 was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review by lot number (63542002 and 63560494) was performed for similar events using keyword does not seat and no other similar complaint was identified.Therefore, based on the available information, device malfunction did not occur and the reported event was unconfirmed.

• Brand Name: HEAL COLLAR 4.5X5.5, 3MM
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11824190
• Report Number: 0002023141-2021-01260
• Device Sequence Number: 19120875
• Product Code: NHA
• UDI-Device Identifier: 00889024015067
• UDI-Public: (01)00889024015067(17)211130(10)63542002
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K111852
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: 11/30/2021
• Device Model Number: HC453
• Device Catalogue Number: HC453
• Device Lot Number: 63542002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1