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 Code Available (3191)
Date of Event	02/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Weight unknown / not provided.Last name unknown / not provided.Email address unknown / not provided.
Event or Problem Description
It was reported fracture of the implant at the neck level.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One osseotite® implant 3.75 x 13mm (oss313) was not returned for investigation.Therefore, visual evaluation could not be performed.The investigation was performed using the applicable instructions for use and risk files.Functional testing and dimensional analysis could not be performed since the devices were not returned.Pre-existing conditions noted on the per were smoker & moderate bone density ¿ type ii.The reported devices had been placed on tooth number 24 (fdi) for approximately 16 years.X-ray & picture evaluation: x-ray or picture images were not provided.Per the applicable ifu, it is stated that breakage may occur when devices are loaded beyond their functional capability.The dhr was not available electronically for the subject lot number (234754) thus could not be further reviewed at the time of the investigation.A notification/request has been sent to manufacturing to pull the dhr for review.The pce will be reopened and updated if there is any indication of nonconformance, or any possible manufacturing issue related to the reported event.Since the dhr was not available, a search in the non-conformance database (tipqa) was conducted with the lot number to discover any non-conformances related to the reported event and subject lot number.No nonconformances were found for the subject lot number.Complaint history review was performed for the reported lot (234754) and no similar event or complaint about nonconforming products was found.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.April 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 and the reported events could not be verified since the products were not returned and no pictorial evidence was provided.The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes.'.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One osseotite® implant 3.75 x 13mm (oss313) was returned for investigation.Visual evaluation of the as returned implant identified that the device was severely fractured/damaged.Functional testing and dimensional analysis could not be performed since the implant was severely fractured/damaged and the screw was not returned.Pre-existing conditions noted on the per were smoker & moderate bone density ¿ type ii.The reported devices had been placed on tooth number 24 (fdi) for approximately 16 years.X-ray or picture images were not provided.Dhr review was completed for the subject lot number (234754).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 were 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 (234754) and no similar event or complaint about nonconforming products was found.April 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, implant malfunction did occur and implant fracture was confirmed.

• 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: 10037810
• Report Number: 0001038806-2020-00754
• Device Sequence Number: 11509678
• Product Code: DZE
• UDI-Device Identifier: 00844868013129
• UDI-Public: (01)00844868013129(17)090316(10)234754(241)OSS313
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/03/2020

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: 03/16/2009
• Device Model Number: OSS313
• Device Catalogue Number: OSS313
• Device Lot Number: 234754
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 06/16/2020; 08/10/2020
• Initial Report FDA Received Date: 05/08/2020
• Supplement Report FDA Received Date: 06/25/2020; 09/03/2020
• 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
• Patient Age: 57 YR