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

Model Number	IIOS4511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Weight unknown / not provided.Expiration date # unknown / not provided.
Event or Problem Description
It was reported that implant was removed due to bone loss facially & dehiscence.Per indicated no injury to patient.Surgical intervention necessary.Patient will have to return to retreat.No delay in procedure.
Additional Manufacturer Narrative
Similar complaints for bone loss related problems have been previously investigated.Refer to attached summary investigation.Visual and dimensional evaluations of the previously returned product have not identified or suggested manufacturing non-conformances.Furthermore, the probability of manufacturing or design defects that might lead to bone loss escaping the available detections is remote and almost nonexistent.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Additionally, all device history record reviews verified that each implant was sterilized per procedure for every device.All complaint data used for the summary investigation was found to be conforming and did not meet capa/hhe/d/ie escalation.Therefore, there were no complaints which confirmed a manufacturing or design related issue that did or could cause or contribute to the reported event.Dhr review was completed for the subject lot number.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 for a similar event and no other complaint was identified.Based on the summary investigation, no malfunction occurred upon investigation and no association between the dental implant and bone loss was found that can explain these events.Therefore, the reported event remains non-verifiable as it is a medical condition.The following sections have been updated: g7: checked "follow-up" h2: checked follow-up type.H3: changed "no" to "yes".
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: DO NOT USE - CERTAIN® PREVAIL® IMPLANT 4/5/4 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9918250
• Report Number: 0001038806-2020-00609
• Device Sequence Number: 701571
• Product Code: DZE
• UDI-Device Identifier: 00844868005858
• UDI-Public: (01)00844868005858(17)150518(10)956546(241)IIOS4511
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

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: 05/18/2015
• Device Model Number: IIOS4511
• Device Catalogue Number: IIOS4511
• Device Lot Number: 956546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 05/28/2020
• 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