MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED IMPLANT 3.25 X 10MM; DENTAL IMPLANT

Model Number	NT3210
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during implant placement , the implant achieved good primary stability.But then, the doctor was unable to place cover screw.The internal thread was damaged.Implant was removed and replaced with success.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: d9: device available for evaluation change ¿no' to 'yes'.H3: device evaluated by manufacturer: change ¿no' to 'yes'.One osseotite® tapered implant 3.25 x 10mm (nt3210) was returned for investigation.Visual evaluation of the as returned product identified/confirmed damaged internal drive feature.Functional testing was not performed due to the nature of the device and event.Pre-existing condition noted on the per was 'moderate bone density'.The device was intended for tooth # 35 (fdi).X-ray & picture evaluation: x-ray or picture images were not provided.Review of appropriate documentation: document reviewed: biomet 3i dental implant ifu (p-iis086gi) rev i - 2022/04/01.Information identified: contraindications, warnings, precautions and potential adverse events.Per the applicable ifu, improper techniques as well as overloading may lead to device failure.Dhr review: dhr review for the lot (2019031344) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (2019031344) for similar events (complaint category keywords: damaged drive feature) and no other complaint was identified.Post market trending review: march post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did occur and the reported event (damaged drive feature) was confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE® TAPERED IMPLANT 3.25 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 13547759
• Report Number: 0001038806-2022-00218
• Device Sequence Number: 14752230
• Product Code: DZE
• UDI-Device Identifier: 00844868011965
• UDI-Public: (01)00844868011965(17)240404(10)2019031344
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2024
• Device Model Number: NT3210
• Device Catalogue Number: NT3210
• Device Lot Number: 2019031344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• 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: 01/27/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 06/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2019
• 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
• Patient Age: 60 YR
• Patient Sex: Female