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

Model Number	HC455
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Abscess (1690); Pain (1994)
Date of Event	07/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Patient weight: not provided.
Event or Problem Description
It was reported that healing abutment became loose.The abutment could not be retained.Implant internal threads are fine.Pain and abscess were reported.Tooth location 16.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.The following sections are being reported: d9: device availability was updated h2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation was added: 3331, 4109 and 4111.H6: investigation findings was added: 180.H6: investigation conclusions was added: 4307.H10: narrative/data was updated.The product was returned.However, the reported event could not be verified as the exact details of event were non verifiable.Based on the evaluation and functional testing, device malfunction has occurred ¿ thread damage.However, there is no existing non-conformance / capa / hhe/d / ie / product hold against the reported device that did or could cause or contribute to the reported event.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when it left zimmer biomet.Dhr review for the lot had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.Functional testing was performed using an applicable in-house implant.The device could not thread into the implant as the threads were damaged.Therefore, the reported event could not be recreated.The complaint is related to the functional performance of the device.A definitive root cause could not be determined.No further investigation or immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: HEAL COLLAR 4.5X5.5, 5MM
• Common Device Name: HEALING ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11716629
• Report Number: 0002023141-2021-01034
• Device Sequence Number: 3444746
• Product Code: NHA
• UDI-Device Identifier: 00889024015074
• UDI-Public: (01)00889024015074(17)221130(10)63879642
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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: 11/30/2022
• Device Model Number: HC455
• Device Catalogue Number: HC455
• Device Lot Number: 63879642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR