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

Model Number	SPMB10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Patient identifier unknown /not provided.Age and date of birth unknown /not provided.Patient sex unknown/not provided.Weight unknown/not provided.Date of event unknown/not provided.Implant date unknown/not provided.Explant date unknown/not provided.Email address unknown/not provided.Pma/510(k) number: k011245 and k002188.
Event or Problem Description
It was reported that implant fractured and was removed.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Additional report submitted to update implant and explant dates and product return date.
Event or Problem Description
No further event information is available at the time of this report.
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 implant was returned for investigation.Visual inspection of the as returned product identified worn markings due to usage, bone, blood and a fracture at the collar.No pre-existing conditions were noted on the per.The reported device location is unkonwn and was used for approximately 5 months.Pictures or x-ray images were not provided.Review of appropriate documentation: documents reviewed: instructions for use for swissplus® and tapered swissplus® implants 9667 rev 2 - 10/19 information identified: 'warnings, precautions'.Dhr review: dhr review was completed for the subject lot number (2020031624).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: complaint history review was performed for the reported lot number (2020031624) for similar event and no other complaint was identified.Review completed utilizing keywords: fracture : implant.Post market trend review: sep 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 occur and the reported event was confirmed.

• 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
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 14652478
• Report Number: 0002023141-2022-01449
• Device Sequence Number: 5693428
• Product Code: DZE
• UDI-Device Identifier: 00889024017467
• UDI-Public: (01)00889024017467(17)250401(10)2020031624
• 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: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2022

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: Lay User/Patient
• Device Expiration Date: 04/01/2025
• Device Model Number: SPMB10
• Device Catalogue Number: SPMB10
• Device Lot Number: 2020031624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 06/07/2022; 11/09/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 06/27/2022; 11/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown