MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE XP IMPLANT 4/5 X 13MM; DENTAL IMPLANT

Model Number	OS4513
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of the event unknown / not provided.Product not returned.
Event or Problem Description
Doctor reported that the implant fracture os4513.Doctor confirmed by phone that the implant remains implanted and won´t be removed.
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).An osseotite xp® implant 4/5 x 13mm (os4513) was returned to barcelona.The investigation has been performed based on the available information.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.No pre-existing conditions were noted on the complaint.The reported device location and length of usage is unknown.Device history record (dhr) review was completed for the subject lot number (150191).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 (150191) for similar event and no other complaint was identified.Based on the available information, device malfunction could not be verified and the reported event was non-verifiable.H3 other text : product not returned.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE XP IMPLANT 4/5 X 13MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10172778
• Report Number: 0001038806-2020-00861
• Device Sequence Number: 3053625
• Product Code: DZE
• UDI-Device Identifier: 00844868012863
• UDI-Public: (01)00844868012863(17)070409(10)150191(241)OS4513
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/09/2007
• Device Model Number: OS4513
• Device Catalogue Number: OS4513
• Device Lot Number: 150191
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/31/2020
• 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