MAUDE Adverse Event Report: BIOMET 3I DO NOT USE -OSSEOTITE XP® IMPLANT 4/5 X 11.5MM; DENTAL IMPLANT

Model Number	OS4511
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).Weight unknown / not provided.Date of event unknown / not provided.Implant date unknown / not provided.Explant date unknown / not provided.Email address unknown / not provided.
Event or Problem Description
It was reported implant fractured.Implant remains in patients mouth.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).An osseotite xp® implant 4/5 x 11.5mm (item # os4511) was not returned.Since product has not been returned, visual/functional evaluation could not be performed.The investigation has been performed based on the available information using the item # and lot # (dhr/ifu/rmf).No pre-existing conditions were noted on the product experience report (per).X-ray images were provided and show the implant in place in the patient before and after the fracture across the threads a device history review was performed and no related nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no additional complaints for this lot.A definitive root cause could not be identified.The following sections have been updated: b4: date of this report.G7: type of report, follow-up number.H2: follow up type.H6: evaluation codes.H10: additional narrative.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: DO NOT USE -OSSEOTITE XP® IMPLANT 4/5 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9632748
• Report Number: 0001038806-2020-00189
• Device Sequence Number: 3141671
• Product Code: DZE
• UDI-Device Identifier: 00844868012856
• UDI-Public: (01)00844868012856(17)110809(10)535430(241)OS4511
• 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): 03/09/2020

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: Health Professional
• Device Expiration Date: 09/08/2011
• Device Model Number: OS4511
• Device Catalogue Number: OS4511
• Device Lot Number: 535430
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 03/09/2020
• 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: 50 YR