MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED IMPLANT 3.25 X 11.5MM; DENTAL IMPLANT

Model Number	NT3211
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Inflammation (1932); Pain (1994); Osteolysis (2377)
Date of Event	03/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the implant trajectory had been deviated and a perforation has occurred in the vestibular table, leaving part of the implant exposed and causing loss of primary stability.Bone fracture with bone loss, inflammation and pain reported.Implant was removed.The doctor reports that another implant was placed at another appointments.The dental position is: fdi 12.
Additional Manufacturer Narrative
Product evaluation: one osseotite® tapered implant 3.25 x 11.5mm (nt3211) was returned for investigation.Visual evaluation of the as returned implant identified bone residue around the external threads due to usage.The device had no apparent signs of malfunction.The device could not be functionally tested for the reported events (bone fracture & bone loss).However, measurements were taken on (b)(6) 2021 using a caliper (id: (b)(4); due date: (b)(6) 2021).Following dimensional analysis and comparison to drawings, the device was determined to be within design specifications.Pre-existing condition noted in the per was low bone density ¿ type iii.The reported device was intended for tooth #12 (universal) when the incident occurred.X-ray & picture evaluation: x-ray or picture images were not provided.Review of appropriate documentation: per the applicable ifu, under the section precautions, it is stated that improper technique can lead to implant failure and loss of supporting bone.Dhr review: dhr review for the lot (2019060190) had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (2019060190) for similar events (complaint category keywords: bone fracture & bone loss) and no other complaint was identified.Post market trending review: may post market trending was reviewed and there were no actionable events or corrective actions for the reported events or product.Therefore, based on the available information and dimensional analysis, device malfunction did not occur.Additionally, the reported event could not be verified as the exact details of events and patient anatomical condition were nonverifiable.Sections updated: b4: date of this report.G3: date pce and investigation results were received.G6: type of report and follow up number.H2: follow up type.H3: device evaluated by manufacturer.H6: adverse event problem codes.H10: manufacturer's narrative.
Event or Problem Description
There is no update to the original complaint description provided.
Event or Problem Description
There is no update to the original complaint description provided.
Additional Manufacturer Narrative
Supplemental medwatch created to correct previously reported investigation results under mfr # 0001038806-2021-00641-1 indicating the implant was placed at site #12 universal as it was actually placed at site #12 fdi.

• Brand Name: OSSEOTITE TAPERED IMPLANT 3.25 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11690680
• Report Number: 0001038806-2021-00641
• Device Sequence Number: 3535310
• Product Code: DZE
• UDI-Device Identifier: 00844868011972
• UDI-Public: (01)00844868011972(17)240614(10)2019060190
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/26/2021

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: 06/14/2024
• Device Model Number: NT3211
• Device Catalogue Number: NT3211
• Device Lot Number: 2019060190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 07/19/2021; 07/26/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 07/26/2021; 07/27/2021
• 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: 67 YR