MAUDE Adverse Event Report: ZIMMER DENTAL IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 10MM; DENTAL IMPLANT

Catalog Number	TSVWH10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Additional 510(k) numbers are k011028 and k013227.
Event or Problem Description
It was reported that the implant was removed due to the implant becoming fractured.Patient heard a crunch while eating resulting in the crown falling off.Patient will return for a replacement implant in the future.Tooth #19.
Event or Problem Description
There is no update to the original complaint description provided.
Additional Manufacturer Narrative
One (1) impl tapered scr-v ha 4.7 mm 4.5mm 10mm (tsvwh10) was returned for investigation.Visual evaluation of the as returned product identified the implant fractured at the collar.Dried blood debris on the external threads.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 # 19 (universal) and was used for approximately 9 years, and 8 months.The customer did not provide any pictures or x-rays.Review of appropriate documentation: instructions for use for tapered screw-vent® and trabecular metal¿ implants 4869 rev 9 ¿ 10/19.Information identified: contraindications, warnings.Dhr review: dhr review was completed for the subject lot number (61782901).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 (61782901) for similar event and no other complaint was identified.Review completed utilizing keywords: fracture implant.Post market trend review: feb post market trending was reviewed and there were no actionable events or corrective actions for the reported event (fracture implant) or product (tsvwh10).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 SCR-V HA 4.7 MM 4.5MM 10MM
• 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: 12711849
• Report Number: 0002023141-2021-03041
• Device Sequence Number: 4270225
• Product Code: DZE
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K061410
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: TSVWH10
• Device Lot Number: 61782901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• 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: 10/04/2021
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 04/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2011
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 68 KG