MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE IMPLANT 3.75 X 13MM; DENTAL IMPLANT

Model Number	OSS313
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/10/2020
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.Weight unknown / not provided.
Event or Problem Description
It was reported that the implant oss313 fractured after 4 years and was removed.Doctor tried to remove the fragment that was osseointegrated with a removal tool but it was not possible, doctor had to use a trephine.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One osseotite® implant 3.75 x 13mm (oss313) was returned for investigation.Visual evaluation of the as returned product identified signs of damage about the threads, and fracturing at the collar.No pre-existing conditions were noted on the per.The reported product was located on an unknown tooth site and used for approximately 4 years.It is noted that the implant was used following the sterile packaging date.The reported event could not be recreated due to the nature of the dental device and event (fracture).Dhr review was completed for the subject lot number 2010100925.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 number (2010100925) for similar event and no other complaint was identified.September post market trending was reviewed and there were no actionable events or corrective actions for the reported event (implant fracture) or product (oss313).Therefore, based on the available information, device malfunction has occurred 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 IMPLANT 3.75 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10429885
• Report Number: 0001038806-2020-01183
• Device Sequence Number: 2171210
• Product Code: DZE
• UDI-Device Identifier: 00844868013129
• UDI-Public: (01)00844868013129(17)151103(10)2010100925(241)OSS313
• 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: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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: Lay User/Patient
• Device Expiration Date: 11/03/2015
• Device Model Number: OSS313
• Device Catalogue Number: OSS313
• Device Lot Number: 2010100925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 11/30/2020
• 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