MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X4.5, 7MM; DENTAL ABUTMENT

Catalog Number	HC347
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The doctor reports that the abutments are malfunctioning as they does not seat properly.The affected dental positions are unknown.The patient did not suffer any negative impact on their health.The doctor reported the procedure not completed with other abutments.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).D4: additional device information unknown / not provided.D10.Concomitant medical products hc347, heal collar 3.5x4.5, 7mm lot 2021120615 x2 and hc345, heal collar 3.5x4.5, 5mm lot 2022050926 x2.H4: device manufacturer date unknown / not provided.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D4: additional device information.D9: device availability.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.Zimvie received one (1) hc347, (heal collar 3.5x4.5, 7mm) for evaluation.Visual evaluation and a functional test was performed, there was signs of use, the abutments threads were discolored.However, the abutment seated in an in-house implant without any issues.Device history record (dhr) review was completed for the subject lot number: 2021120054.No deviations or non-conformance's, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number: 2021120054 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: fit: does not seat.A definitive root cause could not be determined since device malfunction did not occur.The reported event was unconfirmed following functional testing and physical evaluation.Therefore, based on the available information, a device malfunction did not occur.The healing collar seated with an in-house implant as intended.The reported event was not confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: HEAL COLLAR 3.5X4.5, 7MM
• 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19497627
• Report Number: 0002023141-2024-01889
• Device Sequence Number: 17845599
• Product Code: NHA
• UDI-Device Identifier: 00889024015012
• UDI-Public: (01)00889024015012(17)261202(10)2021120054
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K111852
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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 Catalogue Number: HC347
• Device Lot Number: 2021120054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL ABUTMENT SEE H10 NARRATIVE.
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic