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

Model Number	FOS4511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
It was reported that the implant was removed due to bone loss.
Additional Manufacturer Narrative
Zimmerbiomet complaint number: (b)(4).Full osseotite xp® implant 4/5 x 11.5mm (fos4511) was returned for investigation.Visual inspection of the reported product identified severely damaged/fractured implant with dried blood and bone.Customer follow up identified the implant fractured during the removal process of the implant.Functional testing to recreate the reported event could not be performed due to the nature of the devices and event.The reported device could not be measured to verify specifications due to the damaged state of the implant.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.Complainant reported bone loss.He reported devices were returned and the reported event is non-verifiable for both devices as pictures or x-rays were not provided by the customer.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.H3: device evaluated by manufacturer: change ¿no' to 'yes'.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 - FULL 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: 9411487
• Report Number: 0001038806-2019-01514
• Device Sequence Number: 4202694
• Product Code: DZE
• UDI-Device Identifier: 00844868003663
• UDI-Public: (01)00844868003663(17)140609(10)865800(241)FOS4511
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/09/2014
• Device Model Number: FOS4511
• Device Catalogue Number: FOS4511
• Device Lot Number: 865800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 02/12/2020
• 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: 52 YR
• Patient Weight: 65