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 Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that implant failed due to a fracture, both parts of the fractured implant were successfully removed.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4) the following sections have been updated: b4: date of this report b5: describe event or problem g3: date received by manufacturer h1: type of report, follow-up number h2: follow up type h3: device evaluated by manufacturer: change ¿no' to 'yes' h6: evaluation codes h10: additional narrative one osseotite® implant 3.75 x 13mm (oss313) was returned for investigation.Visual evaluation of the as returned product identified fracture across the threads and bone residue around due to usage.Functional testing and dimensional analysis could not be performed since the device was fractured.No pre-existing condition were noted on the product expereince report.The reported device had been placed on tooth 43 (fdi) for an unknown period of time.Per the applicable ifu, it is stated that breakage may occur following improper techniques used and when device is loaded beyond its functional capability.Device history rrecord review for the lot (2016100456) had revealed no deviations nor non-conformances which could have caused or contributed to 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 number (2016100456) for similar events (complaint category keywords: functional: fracture: implant) and no other complaint was identified under (b)(4).June post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did occur and the reported event 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: 11937680
• Report Number: 0001038806-2021-00934
• Device Sequence Number: 14509837
• Product Code: DZE
• UDI-Device Identifier: 00844868013129
• UDI-Public: (01)00844868013129(17)211019(10)2016100456
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/20/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/19/2021
• Device Model Number: OSS313
• Device Catalogue Number: OSS313
• Device Lot Number: 2016100456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/14/2021
• Supplement Date Received by Manufacturer: 08/10/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 08/20/2021
• 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: 73 YR