MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE IMPLANT 4X 15MM; DENTAL IMPLANT

Model Number	FOS415
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.
Event or Problem Description
It was reported the implant and the screw fractured and were removed from patient´s mouth.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).The following sections have been updated: b4: date of this report b5: describe event or problem d4: expiration date h1: type of report, follow-up number h2: follow up type h3: device evaluated by manufacturer: change ¿no' to 'yes' h6: evaluation codes h10: additional narrative one full osseotite® implant (fos415) and one unknown legacy biomet screw were returned for investigation.Visual evaluation of the as returned products identified fracture across the threads.Additionally, there was bone residue around the external threads which were damaged possibly during removal.Functional testing could not be performed since the products were fractured.Pre-existing condition noted on the per was 'moderate bone density ¿ type ii'.The reported devices have been placed on an unknown tooth location for approximately 9 years.X-ray and picture images were not provided.Documents reviewed: biomet 3i dental implant ifu (p-iis086gi) rev g - october 2019 / biomet 3i restorative products ifu (p-iis086gr) rev f - october 2019.Information identified: warnings and precautions.Per the applicable ifu, breakage may occur when device is loaded beyond its functional capability.Dhr and complaint history review could not be performed as the lot/item number was not available.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.Dhr review for the lot (2011100388) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.: complaint history review was performed for the reported lot (2011100388) and no similar event or complaint was found.January post market trending was reviewed and there were no actionable events or corrective actions for the reported events or products.Therefore, based on the available information, device malfunction did occur and the reported events were confirmed.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The following sections have been updated: b4: date of this report b5: describe event or problem d4:udi number updated to unknown g3: date received by manufacturer h1: type of report, follow-up number h2: follow up type h10: additional narrative.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: FULL OSSEOTITE IMPLANT 4X 15MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11138800
• Report Number: 0001038806-2021-00035
• Device Sequence Number: 2915612
• Product Code: DZE
• UDI-Device Identifier: 00844868003632
• UDI-Public: (01)00844868003632(17)161025(10)2011100388(241)FOS415
• 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: 2012
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2016
• Device Model Number: FOS415
• Device Catalogue Number: FOS415
• Device Lot Number: 2011100388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/17/2020
• Supplement Date Received by Manufacturer: 04/14/2021; 05/19/2021
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 04/19/2021; 05/19/2021
• 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