MAUDE Adverse Event Report: ZIMMER DENTAL CONTOUR ABUTMENT, 2.9MMD PLATFORM, 3.7MMD EMERGENCE PROFILE, 1.5MM CUFF; RESTORATIVE ABUTMENT

Model Number	N/A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted to report (b)(4).The following information is unknown at the time of this report: the reported device has been received investigation has not yet begun.Once investigation is complete, a follow up medwatch report will be submitted.(b)(6).
Event or Problem Description
It was reported that the abutment screw could not be released from the abutment and abutment was cut off.There was no report of patient injury.
Event or Problem Description
It was reported that the abutment screw could not be released from the abutment and abutment was cut off.There was no report of patient injury.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.The following sections are being reported: b5: it was reported that the abutment screw could not be released from the abutment and abutment was cut off.There was no report of patient injury.D4: expiration date: 14 nov 2022 udi: (b)(4).G4: (b)(6) 2019, g7: follow up, h1: serious injury, h2: additional information, device evaluation, h3: yes, evaluation summary attached.H4: (b)(6) 2017.H6: method, results, conclusion codes h10: manufacturer narrative the reported device was received for evaluation.Visual inspection of the as returned product identified damage at the abutment drive feature and screw head from removal.Functional testing could not be performed, both parts were too badly damaged to engage properly.The reported event of an abutment screw that could not be released from the abutment could not be confirmed.A device history record (dhr) review was performed for the reported device lot.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.A complaint history review was performed for the reported lot for similar cause and no other complaint was identified.A definitive root cause for the reported event could not be determined.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.

• Brand Name: CONTOUR ABUTMENT, 2.9MMD PLATFORM, 3.7MMD EMERGENCE PROFILE, 1.5MM CUFF
• Common Device Name: RESTORATIVE ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 1900 aston avenue; carlsbad CA 92008
• MDR Report Key: 8546532
• Report Number: 0002023141-2019-00177
• Device Sequence Number: 18922537
• Product Code: DZE
• UDI-Device Identifier: 00889024343092
• UDI-Public: (01)00889024343092(17)221114(10)2017110940(241)CANP31S
• Combination Product (Y/N): N
• PMA/510(K) Number: K142082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2022
• Device Model Number: N/A
• Device Catalogue Number: CANP31S
• Device Lot Number: 2017110940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 07/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention