MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE¿ IMPLANT 6 X 11.5MM; DENTAL IMPLANT

Catalog Number	OSS611
Medical Device Problem Codes	Failure to Osseointegrate (1863); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sinus Perforation (2277)
Date of Event	10/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor reported non integration and sinus perforation at tooth site 17, possibly due to pressure of temporary prosthetic during healing, and implant was removed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight: unknown / not provided.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) oss611, (osseotitel implant 6 x 11.5mm) for evaluation.Visual evaluation was performed, the implant had signs of use and slight wear, however, no damage to the implant was identified that would cause or contribute to the event.Device history record (dhr) review was completed for the subject lot number 2022101277.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 2022101277 for similar events and no other complaint was identified.Review completed utilizing keywords: dental: functional: non-integration: perforated sinus 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 with all the available information provided.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.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE¿ IMPLANT 6 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: 20805584
• Report Number: 0001038806-2024-02766
• Device Sequence Number: 9302352
• Product Code: DZE
• UDI-Device Identifier: 00844868013334
• UDI-Public: (01)00844868013334(17)271110(10)2022101277
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/12/2025

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 Catalogue Number: OSS611
• Device Lot Number: 2022101277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• 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: 11/28/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic