MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 4/3 X 8.5MM; DENTAL IMPLANT

Model Number	XIITP4385
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Last name address unknown / not provided.
Event or Problem Description
It was reported that the screw access would not engage in any parts or pieces.It was reported that the screw access was stripped.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The reported device was returned for investigation.Visual evaluation of the returned product identified no apparent malfunction with the returned implant.Signs of use was observed.The device was functionally tested with an in-house driver and the implant engaged/disengaged as intended.Pre-existing condition noted on the product experience report (per) was diabetes.The reported device was located on tooth # 3 and was used for approximately 2 years, and 6 months.The customer did not provide any pictures or x-rays.A device history record (dhr)review was performed and no related deviations or nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no related complaints for this product lot.Complainant reported that the screw access was stripped.The reported complaint could not be confirmed.A definitive root cause for this complaint could not be determined.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 4/3 X 8.5MM
• 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: 12638594
• Report Number: 0001038806-2021-01983
• Device Sequence Number: 16471077
• Product Code: DZE
• UDI-Device Identifier: 00844868022107
• UDI-Public: (01)00844868022107(17)220929(10)2017091286
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K130949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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: Health Professional
• Device Expiration Date: 09/29/2022
• Device Model Number: XIITP4385
• Device Catalogue Number: XIITP4385
• Device Lot Number: 2017091286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• 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: 09/27/2021
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female