MAUDE Adverse Event Report: BIOMET 3I DO NOT USE-FULL OSSEOTITE CERTAIN IMPLANT 4 X 11.5MM; DENTAL IMPLANT

Model Number	IFOS411
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported implant fractured and was removed.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).The following sections have been updated: d4: unique identifier (udi) number changed to unknown.One full osseotite® certain® implant (ifos411) was returned for investigation.Visual evaluation of the as returned product identified minor fracture at the platform and gouges around the collar.Additionally, there was bone/blood residue around the external/internal threads due to usage.Device history record (dhr) review for the lot (2012040405) had revealed no deviations nor non-conformances which could have caused or contributed the reported event.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 (2012040405) and no similar event or complaint was found.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.

• Brand Name: DO NOT USE-FULL OSSEOTITE CERTAIN IMPLANT 4 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11054208
• Report Number: 0001038806-2020-02108
• Device Sequence Number: 14124462
• Product Code: DZE
• UDI-Device Identifier: 00844868005162
• UDI-Public: (01)00844868005162(17)170423(10)2012040405(241)IFOS411
• 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: 2013
• 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): 03/26/2021

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: 04/23/2017
• Device Model Number: IFOS411
• Device Catalogue Number: IFOS411
• Device Lot Number: 2012040405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/26/2020
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 03/26/2021
• 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