MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE¿ IMPLANT 4 X 11.5MM; DENTAL IMPLANT

Catalog Number	OSS411
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).A4: patient weight unknown / not provided.D4: additional device information unknown / not provided.H4: device manufacturer date unknown / not provided.
Event or Problem Description
Doctor reported implant fracture at tooth site 47.The remaining part was removed with trephine preserving the walls.Patient has been rescheduled for new implant placement.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).One osseotite implant, (oss411) was returned for evaluation.Visual/physical evaluation of the as returned product identified fracture around the threads.Dhr review for the lot (2016101969) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimvie.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number 2016101969 for similar events and 1 other complaint was identified.Review completed utilizing keywords: fracture: implant.Based on the investigation and risk management file review, the most likely root causes determined were patient factors.Therefore, based on the available information, device malfunction did occur, and the reported event was confirmed.No further investigation or 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.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.

• Brand Name: OSSEOTITE¿ IMPLANT 4 X 11.5MM
• 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: 17040397
• Report Number: 0001038806-2023-01048
• Device Sequence Number: 7011834
• Product Code: DZE
• UDI-Device Identifier: 00844868013181
• UDI-Public: (01)00844868013181(17)211110(10)2016101969
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2023

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/09/2021
• Device Catalogue Number: OSS411
• Device Lot Number: 2016101969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2016
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 58 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic