MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 5/4 X 15MM; DENTAL IMPLANT

Model Number	XIITP5415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Inflammation (1932); No Code Available (3191)
Date of Event	11/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).Weight unknown / not provided.Summary investigation.
Event or Problem Description
It was reported that the pt came in for post-op and his gums were inflamed.Gave peridex rinse but a month later came in to have implant removed.Site was grafted upon removal.Pt was struck in the face at work on (b)(6) 2019 causing #22 to become loose.Patient suffered bone loss.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).One osseotite® tapered certain® prevail® implant 5/4 x 15mm (xiitp5415) was returned for investigation.Visual inspection of the as returned product identified signs of use, dried bone and no apparent malfunction.Functional testing to recreate the reported events could not be performed due to the nature of the device & events.The reported device was measured and was verified to match drawing specifications.Patient attribute reported on the product experience report (per) was smoker.Additionally, the customer reported the patient had abscess and inflammation; however, those conditions are a symptom of the reported events and will not be individually investigated.The reported device was located on tooth # 22 and was used for approximately 2 months.The customer did not provide any pictures or x-rays.A device history review was performed and no related deviations or nonconformances were noted.Complaint history review was performed for the reported lot number (2018052471) for similar events and one other relative complaint was identified.Sterilization record for the implant was reviewed and verified to have passed all sterilization activities with no issues or non-conformities identified.Complainant reported that the pt came in for post-op and his gums were inflamed.Doctor gave peridex rinse but a month later came in to have implant removed.Patient was also reported to have been struck in the face at work so the implant to become loose.Patient suffered from bone loss and had implant removed and will return for replacement after 3-6 months.Site was grafted with implant removal.The product was returned and the reported complaint could not be verified as the device did not malfunction, pictures or x-rays were not provided and medical events are non-verifiable events.A definitive root cause for this complaint could not be determined.The following sections have been updated: b4: date of this report.G4: date received by manufacturer.G7: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer: change ¿no' to 'yes'.H6: method code 10.H10: additional narrative.The following sections have been corrected: h3: device evaluated by manufacturer: if other, specify - summary investigation.H6: patient code 3191.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE® TAPERED CERTAIN® PREVAIL® IMPLANT 5/4 X 15MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9503898
• Report Number: 0001038806-2019-01669
• Device Sequence Number: 13973048
• Product Code: DZE
• UDI-Device Identifier: 00844868022183
• UDI-Public: (01)00844868022183(17)230608(10)2018052471(241)XIITP5415
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K130949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2020

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: Health Professional
• Device Expiration Date: 06/08/2023
• Device Model Number: XIITP5415
• Device Catalogue Number: XIITP5415
• Device Lot Number: 2018052471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 02/14/2020
• 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: 41 YR