MAUDE Adverse Event Report: ZIMMER DENTAL IMPL SWISSPLUS OCTAGON 4. 8MM 10MM; DENTAL IMPLANT

Model Number	OPWB10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the implant was removed due to pain.
Additional Manufacturer Narrative
Zimmerbiomet complaint number cmp-0648240 the following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes.' one impl swissplus octagon 4.8mm 10mm (opwb10) was returned for investigation.Visual inspection of the as returned product identified moderate signs of wear and debris about the implant threads.No pre-existing conditions were noted on the per.The reported product was located on tooth # 26 (fdi) and used for approximately 5 months.The reported event could not be recreated due to the nature of the dental device and event (medical condition).Review of appropriate documentation: documents reviewed: ifu 9667 rev 2 - 10/19; warnings; page 1.Dhr review was completed for the subject lot number 63769048.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 was performed for the reported lot number (63769048) for similar event and no other complaint was identified.January post market trending was reviewed and there were no actionable events or corrective actions for the reported event (patient pain) or product (opwb10).Therefore, based on the available information, device malfunction has not occurred and the reported event was non-verifiable.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMPL SWISSPLUS OCTAGON 4. 8MM 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10919480
• Report Number: 0002023141-2020-02116
• Device Sequence Number: 2713717
• Product Code: DZE
• UDI-Device Identifier: 00889024016026
• UDI-Public: (01)00889024016026(17)221031(10)63769048
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K011245
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: OPWB10
• Device Catalogue Number: OPWB10
• Device Lot Number: 63769048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 11/30/2020
• Supplement Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR