MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE¿ TAPERED CERTAIN¿ PREVAIL¿ IMPLANT 6/5 X 8.5MM; DENTAL IMPLANT

Model Number	XIITP6585
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sinus Perforation (2277)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the implant migrated into sinus of the patient.The patient will return to the clinic to explore and retrieve the implant.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Additional Manufacturer Narrative
This report is being submitted to relay corrected information for the initial report 0001038806-2023-00137.Correction: the device lot number is being updated to 2021051434.
Event or Problem Description
Upon follow up, the customer provided the correct implant lot number.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.D9: device availability and return date were updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: investigation type codes were added: 3331, 4109, 4110 and 4111.H6: investigation findings code was added: 213.H6: investigation conclusions codes were added: 67 and 4310.H10: narrative/data was updated.One (1) osseotite tapered certain prevail implant 6/5 x 8.5mm (xiitp6585) & one (1) osseotite tapered certain prevail implant 6/5 x 8.5mm (xiitp6585) were returned for investigation.Visual evaluation of the as returned product identified signs of use.No malfunction identified.Based on the evaluation, device malfunction has not occurred.Additionally, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported devices that could cause or contribute to the reported event.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or devices.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the product was within specifications and likely conforming when it left zimvie.Dhr review was completed for the subject lot numbers (2021070460 & 2021051434).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot numbers were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot numbers (2021070460 & 2021051434) for similar events and no other complaint was identified.The reported event could not be recreated due to the nature of the dental device and event, and the complaint is not related to the functional performance of the devices.A definitive root cause could not be identified.However, based on the investigation, ifu and risk file review, the most likely causes determined from the investigation are clinician places implant in a patient with patient factors (e.G., poor hygiene, periodontal issues, pre-existing medical conditions), clinician inadvertently selects a length of implant that is too long for the depth of osteotomy prepared.No further investigation and no immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: OSSEOTITE¿ TAPERED CERTAIN¿ PREVAIL¿ IMPLANT 6/5 X 8.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16240883
• Report Number: 0001038806-2023-00137
• Device Sequence Number: 6306851
• Product Code: DZE
• UDI-Device Identifier: 00844868022244
• UDI-Public: (01)00844868022244(17)260616(10)2021051434
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K130949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/10/2023

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: 06/16/2026
• Device Model Number: XIITP6585
• Device Catalogue Number: XIITP6585
• Device Lot Number: 2021051434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 02/06/2023; 05/04/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 02/08/2023; 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male