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

Catalog Number	OSS411
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Event or Problem Description
It was reported that at the time of implant placement, the patient was in pain with a strong feeling of compression.When the implant #37 was half screwed in, the patient panicked, so doctor unscrewed it and removed it.The implant is no longer sterile.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) oss411, (osseotite implant 4 x 11.5mm) for evaluation.Visual evaluation and a functional test was performed, the returned implant & mount have signs of use.The implant has apparent bone / tissue attached to external threads.The returned implant & mount were identified as reported however, no apparent malfunction was identified with the implant or mount that would contribute to the reported events.The implant disengaged/release from the mount as intended during a functional test.Implant & mount matched prints where measured.Dhr review was completed for the subject lot number 2120003147.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2120003147 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : medical : pain, dental : functional : lack of primary stability and dental : functional : does not disengage/release.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was inadequate treatment planning and patient factors.Therefore, based on the available information, a device malfunction did not occur.No damage to the implant was identified.The reported event was non-verifiable.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19790556
• Report Number: 0001038806-2024-01575
• Device Sequence Number: 7283750
• Product Code: DZE
• UDI-Device Identifier: 00844868013181
• UDI-Public: (01)00844868013181(17)280920(10)2120003147
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063286
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 12/12/2024

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 Catalogue Number: OSS411
• Device Lot Number: 2120003147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• 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
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic