MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® CERTAIN® IMPLANT 5 X 8.5MM; DENTAL IMPLANT

Model Number	IOSS585
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Information (3190)
Date of Event	11/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier unknown/not provided.Weight unknown/not provided.Email address unknown/not provided.
Event or Problem Description
It was reported that the implant ioss585 failed due to infection and bone loss.The doctor also mentions a large bone loss around the implant.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4) the following sections have been updated: b4: date of this report; b5: describe event or problem; g4: date received by manufacturer ; g7: type of report, follow-up number ; h2: follow up type; h3: device evaluated by manufacturer; h6: event problem and evaluation codes; h10: additional narrative.The product was returned and the reported events are non-verifiable as the device did not malfunction, pictures or x-rays were not provided and medical events are non-verifiable events.Based on the evaluation, the device malfunction has not occurred.Additionally, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported device that did or could cause or contribute to the reported events.Device history record (dhr) review was completed for the subject lot number (2012071856).It was confirmed that all operations and inspections were executed as per applicable procedure.Complaint history review was performed for the reported lot number (2012071856) for similar events and no other relative complaint was identified.The reported events could not be recreated due to the nature of the dental device and events (medical conditions).The complaint is not related to the functional performance of the device.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE® CERTAIN® IMPLANT 5 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9487266
• Report Number: 0001038806-2019-01622
• Device Sequence Number: 16663820
• Product Code: DZE
• UDI-Device Identifier: 00844868007197
• UDI-Public: (01)00844868007197(17)170828(10)2012071856(241)IOSS585
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2020

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: 08/28/2017
• Device Model Number: IOSS585
• Device Catalogue Number: IOSS585
• Device Lot Number: 2012071856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/26/2020
• 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: 55 YR