MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED CERTAIN IMPLANT 5 X 8.5MM; DENTAL IMPLANT

Model Number	INT585
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
Doctor reported the implant after 5 months of definitive loading relocate into sinus.Doctor removed the implant opening a lateral window of the maxilar sinus.Patient felt pain.
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.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: adverse event problem.H10: additional narrative.One osseotite® tapered certain® implant 5 x 8.5mm (int585) was returned for investigation.Visual evaluation of the as returned product identified some signs of use and debris attached to the external threads but no apparent malfunction.The device could not be functionally tested for the reported failures (perforated sinus), however, measurements were taken using a caliper.Device history record (dhr) review was completed for the subject lot number 2017020656.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 (2017020656) using keyword relocation into sinus, perforated sinus and no other complaint was found.Therefore, based on the available information and dimensional analysis, device malfunction did not occur.Additionally, the reported events could not be verified since they are medical conditions.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE TAPERED CERTAIN IMPLANT 5 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 12245127
• Report Number: 0001038806-2021-01403
• Device Sequence Number: 5244672
• Product Code: DZE
• UDI-Device Identifier: 00844868006732
• UDI-Public: (01)00844868006732(17)220222(10)2017020656
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• 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): 11/02/2021

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: Lay User/Patient
• Device Expiration Date: 02/22/2022
• Device Model Number: INT585
• Device Catalogue Number: INT585
• Device Lot Number: 2017020656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention