MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X4.5, 3MM; DENTAL ABUTMENT

Catalog Number	HC343
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier unknown / not provided a2: age at time of event unknown / not provided a4: patient weight unknown / not provided d4: additional device information unknown / not provided d4: unique identifier (udi) number not available e1: reporter phone: (b)(6).H4: device manufacturer date unknown / not provided.
Event or Problem Description
The doctor reports that the abutment does not seat or screw properly onto the implant.The procedure was not completed using another abutment.The patient did not suffer any negative impact on their health as a result of the event.The affected dental position is unknown.Bone type: unknown.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number cmp-(b)(4).Zimvie received one (1) hc343, (heal collar 3.5x4.5, 3mm) 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.Dhr review was completed for the subject lot number 2018062075.No deviations or non-conformances, 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 2018062075 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : fit : does not seat the customer did not submit images for the reported event.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.H3 other text : investigation results.

• Brand Name: HEAL COLLAR 3.5X4.5, 3MM
• 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: 18491641
• Report Number: 0002023141-2024-00046
• Device Sequence Number: 7188881
• Product Code: NHA
• UDI-Device Identifier: 00889024014992
• UDI-Public: (01)00889024014992(17)230626(10)2018062075
• 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
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 05/28/2024

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: Lay User/Patient
• Device Expiration Date: 06/26/2023
• Device Catalogue Number: HC343
• Device Lot Number: 2018062075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2018
• 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 Sex: Male
• Patient Ethnicity: Non Hispanic