MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SP 4.8MM 12M M OCTAGON; DENTAL IMPLANT

Model Number	SPWB12
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Pma/510(k) number k011245 and k002188.
Event or Problem Description
It was reported the implant fractured and was removed using a trephin and new implant was placed.Crown was restored and the implant fractured during normal function.The implant buccal retention wall fractured.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.D6: implant date unknown / not provided.D9: device available for evaluation change ¿no' to 'yes'.G3: date received by manufacturer.H1: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer: change ¿no' to 'yes'.H6: evaluation codes.H10: additional narrative.One (1) impl tapered sp 4.8mm 12m m octagon (spwb12) was returned for investigation.Visual evaluation of the as returned product identified the implant collar fractured.Screw fragment was also identified in the implant drive feature.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.A pre-existing condition noted on the per was unknown bone density type.The reported device was located on tooth 36 (fdi) and was used for approximately 6 years.Device hitory record (dhr) review was completed for the subject lot number (63241210).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 (63241210) for similar event and no other complaint was identified.September post market trending was reviewed and there were no actionable events or corrective actions for the reported events (fracture implant & screw fracture).No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: IMPL TAPERED SP 4.8MM 12M M OCTAGON
• 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: 12173324
• Report Number: 0002023141-2021-01808
• Device Sequence Number: 16394126
• Product Code: DZE
• UDI-Device Identifier: 00889024017573
• UDI-Public: (01)00889024017573(17)201231(10)63241210
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K082639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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: 12/31/2020
• Device Model Number: SPWB12
• Device Catalogue Number: SPWB12
• Device Lot Number: 63241210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• 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: 06/23/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2015
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 86 KG