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	10/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmerbiomet complaint number: (b)(4).Expiration date and unique identifier (udi) number unknown / not provided.
Event or Problem Description
It was reported that there was damaged to the implant's drive feature.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem d4: additional device information g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h4: device manufacturer date h6: adverse event problem h10: additional narrative one (1) osseotite tapered certain implant 3.25 x 10mm (xifnt3210) was returned for investigation.Visual evaluation of the as returned product identified bone debris on the external threads.There was also damage seen on the external threads and collar area.Internal thread damage.No visible damage to cover screw.Functional testing to recreate the reported event verified that the returned cover screw wouldn¿t seat in the damaged implant.The screw encountered resistance while driving into the implant.It wasn¿t a flush/smooth connection.The same cover screw was able to seat into an in-house implant without any issues.A pre-existing condition noted on the per was not reported.Bone density was moderate density (type ii).The reported device was located on tooth # 36 (fdi) and was implanted and explanted on the same day.Dhr review for the lot 2022050968 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 zimvie.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number 2022050968 for similar events.Review completed utilizing keywords: dental : functional : damaged drive feature.Therefore, based on the available information, device malfunction did occur and the reported event 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: 15824081
• Report Number: 0001038806-2022-01786
• Device Sequence Number: 12297824
• Product Code: DZE
• UDI-Device Identifier: 00844868011965
• UDI-Public: (01)00844868011965(17)270621(10)2022050968
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 03/16/2023

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 Model Number: NT3210
• Device Catalogue Number: NT3210
• Device Lot Number: 2022050968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• 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: 10/26/2022
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 90 KG