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

Model Number	OSS413
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported implant was removed due to fracture.
Additional Manufacturer Narrative
Zimmer biomet complaint number cmp- (b)(4).A osseotite® implant 4 x 13mm (oss413) and unk biomet screw were returned for investigation.Visual evaluation of the as returned product identified worn markings due to usage and a fracture on the collar along with a fracture screw inside implant.Pre-existing conditions noted on the per are bruxism and clenching of the teeth.Device history record (dhr) review was completed for the subject lot number (2011070473).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.Dhr review and complaint history review could not be performed for the unknown biomet screw, as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.Complaint history review was performed for the reported lot number (2011070473) for similar event and no other complaint was identified.No complaint history review could be performed without relevant lot and item information for the unknown biomet screw.Based on the available information, device malfunction did occur and the reported events are confirmed.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE 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: 10377726
• Report Number: 0001038806-2020-01089
• Device Sequence Number: 2942508
• Product Code: DZE
• UDI-Device Identifier: 00844868013198
• UDI-Public: (01)00844868013198(17)160729(10)2011070473(241)OSS413
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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: Health Professional
• Device Expiration Date: 07/29/2016
• Device Model Number: OSS413
• Device Catalogue Number: OSS413
• Device Lot Number: 2011070473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 08/07/2020
• 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