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

Model Number	INT585
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).
Event or Problem Description
Doctor reported malfunction.Another implant was placed on the same surgery the same day.
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).One osseotite® tapered certain® implant 5 x 8.5mm (int585) and one internal connection universal placement driver tip ¿ short (iipdtus) were returned for investigation.Visual evaluation of the as returned products identified signs of wear and dried blood and bone residue around the external threads of the implant due to usage.Functional testing was performed to disengage the devices unsuccessfully.They were determined to be stuck together.Device history record (dhr) review for the lots (2019020460 / 1218697) 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.Lots were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the lots (2019020460 / 1218697) for similar events and no other complaint was identified.Therefore, based on visual inspection and functional testing, 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 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: 10173383
• Report Number: 0001038806-2020-00869
• Device Sequence Number: 11526423
• Product Code: DZE
• UDI-Device Identifier: 00844868006732
• UDI-Public: (01)00844868006732(17)240222(10)2019020460(241)INT585
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

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: 02/22/2024
• Device Model Number: INT585
• Device Catalogue Number: INT585
• Device Lot Number: 2019020460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/29/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 80