MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SP 3.7MM 10M M HEXAGON; DENTAL IMPLANT

Model Number	SPMB10
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	12/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Title unknown/ not provided first/given name: unknown / not provided last name unknown / not provided email address unknown / not provided occupation unknown / not provided pma/510(k): k011245 and k002188.
Event or Problem Description
It was indicated implant removed due to pain.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).An impl tapered sp 3.7mm 10m m hexagon (spmb10) was returned for investigation.Visual evaluation of the as returned product identified blood residue on threads and the drive feature.No damage identified.Functional testing to recreate the reported event could not be performed due to the nature of the event.No pre-existing conditions were noted on the product experience report.The reported device location is unknown and was used for approximately 5 months and 12 days.Pictures or x-ray images were not provided.Dhr review was completed for the subject lot number (2019030256).It was confirmed that all operations and inspections were executed as per the 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.Sterilization record (op511) was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review was performed for the reported lot number (2019030256) for a similar event and no other complaint was identified.March post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction did not occur and the reported event was non-verifiable.The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes'.

• Brand Name: IMPL TAPERED SP 3.7MM 10M M HEXAGON
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9841152
• Report Number: 0002023141-2020-00562
• Device Sequence Number: 13644283
• Product Code: DZE
• UDI-Device Identifier: 00889024017467
• UDI-Public: (01)00889024017467(17)240325(10)2019030256(241)SPMB10
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K082639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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: 03/25/2024
• Device Model Number: SPMB10
• Device Catalogue Number: SPMB10
• Device Lot Number: 2019030256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 05/12/2020
• 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: 74 YR
• Patient Weight: 75