MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE® IMPLANT 3.75 X 13MM; DENTAL IMPLANT

Model Number	OSS313
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during the integration the palatine regeneration was greater than the vestibular one, so that it modified the insertion axis.The implant was removed and flap and suturing were performed.Tooth site 23.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number: (b)(4).The following sections have been updated: b4: date of this report.B5: describe event or problem.G3: date received by the manufacturer.H1: type of report, follow-up number.H2: follow up type.H3: device evaluated by manufacturer: change ¿no' to 'yes'.H6: evaluation codes.H10: additional narrative.One osseotiteâ® implant 3.75 x 13mm (oss313) was returned for investigation.Visual evaluation of the as returned implant identified signs of use and wear but no apparent signs of malfunction.The device could not be functionally tested for the reported failure/medical event.No pre-existing patient condition was noted on the per.The reported device had been placed on tooth 23 for approximately 1 year.Measurements were taken using cal3845 ¿ due date: sep 02, 2022.Following comparison to drawings, the device was determined to be within specification.X-ray & picture evaluation: x-ray or picture images were not provided.Review of appropriate documentation: document reviewed: biomet 3i dental implant ifu (p-iis086gi) rev i - 2022/04/01.Information identified: warnings.Per the applicable ifu, 'physiological and anatomical conditions may affect the performance of dental implants'.Dhr review: dhr review for the lot: (2019080029) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event after implantation of the device.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Sterilization record review: all sterilization activities were conducted with no nonconformities per sterilization record.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.Complaint history review: complaint history review was performed for the reported lot number: (2019080029) for similar events (complaint category keywords: medical: other) and no other complaint was identified.Post market trending review: july post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did not occur.The reported event could not be verified as the exact details of event and patient physiological/anatomical conditions were nonverifiable.

• Brand Name: OSSEOTITE® IMPLANT 3.75 X 13MM
• 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: 14278157
• Report Number: 0001038806-2022-00617
• Device Sequence Number: 15002573
• Product Code: DZE
• UDI-Device Identifier: 00844868013129
• UDI-Public: (01)00844868013129(17)240917(10)2019080029
• 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: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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: 09/17/2024
• Device Model Number: OSS313
• Device Catalogue Number: OSS313
• Device Lot Number: 2019080029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2022
• 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: 04/11/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2019
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male