MAUDE Adverse Event Report: BIOMET 3I FULL OSSEOTITE TAPERED CERTAIN IMPLANT 4 X 13MM; DENTAL IMPLANT

Model Number	IFNT413
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the patient noticed with a loose implant at tooth location #5.Implant was placed (b)(6) 2013 and removed due to fracture on (b)(6) 2020.No patient implant reported and patient has a history of heart disease.
Additional Manufacturer Narrative
One full osseotite® tapered certain® implant (ifnt413), abutment and screw were returned for investigation (images 1 ¿ 7).There were no allegations against the abutment and screw.Therefore, the investigation addresses only the implant and the associated fracture event.Visual evaluation of the as returned implant identified bone residue and minor signs of wear due to usage.The implant was not fractured.Functional testing was performed using the returned abutment and screw.The implant was able to assemble and disassemble with the devices as normal.Pre-existing condition noted on the per was heart disease.The reported device had been placed on tooth #5 (unknown notation system) for approximately 7 years.X-ray/image was provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (2013030222).It was confirmed that all operations and inspections were executed as per applicable procedures.No deviations or non-conformances, which could have caused or contributed to the reported event were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was completed for the subject lot number (2013030222) and no other complaint was identified.Based on the available information and functional testing, device malfunction did not occur and the reported event was unconfirmed.The following sections have been updated: b4: date of this report.G4: date received by manufacturer.G7: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Mfr report number 0001038806-2020-01727, section "d4: device udi number" was submitted with udi # (b)(4).In error.Associated lot #2013030222 was manufactured prior to 24-sep-2015, as a result, a udi number is not required.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: FULL OSSEOTITE TAPERED CERTAIN IMPLANT 4 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10774897
• Report Number: 0001038806-2020-01727
• Device Sequence Number: 3196204
• Product Code: DZE
• UDI-Device Identifier: 00844868005025
• UDI-Public: (01)00844868005025(17)180313(10)2013030222(241)IFNT413
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/09/2021

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: 03/13/2018
• Device Model Number: IFNT413
• Device Catalogue Number: IFNT413
• Device Lot Number: 2013030222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 01/21/2021; 02/08/2021
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 01/22/2021; 02/09/2021
• 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
• Patient Age: 55 YR