MAUDE Adverse Event Report: BIOMET 3I 3I T3® EX HEX PARALLEL WALLED IMPLANT 5 X 10MM; DENTAL IMPLANT

Model Number	BOES510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.
Event or Problem Description
It was reported that three months after placement, the implant boes510 in dental site 19 was removed due to peri-implantitis.
Additional Manufacturer Narrative
Supplemental medwatch 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.Two (2) 3i t3® ex hex parallel walled implants 5 x 10mm (boes510) were returned for investigation.Visual evaluation of the as returned products identified signs of wear due to usage around the external threads, collar and the platform.There was presence of debris (bone residue) around the implant threads.The external hex on one of the implant was damaged, likely from the removal process.The products matched print specifications where measured against drawing.No pre-existing conditions were noted on the per.The reported products were located on tooth sites 36 and 46 (fdi), and used for approximately 5.5 months.The customer has not provided additional pictures or x-ray images of the implant sites.Device history record review was completed for the subject lot number 2013120418.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance, which could have caused or contributed to the reported events 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 (2013120418) for similar events and no other complaint was identified.A definitive root cause could not be identified.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 3I T3® EX HEX PARALLEL WALLED IMPLANT 5 X 10MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9590103
• Report Number: 0001038806-2020-00114
• Device Sequence Number: 10929478
• Product Code: DZE
• UDI-Device Identifier: 00844868032519
• UDI-Public: (01)00844868032519(17)190114(10)2013120418(241)BOES510
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K133049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

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: 01/14/2019
• Device Model Number: BOES510
• Device Catalogue Number: BOES510
• Device Lot Number: 2013120418
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 03/12/2020
• 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: 56 YR