MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC REPLANT IMPLANT CLOSED-TRAY TRANSFER; DENTAL IMPLANT

Catalog Number 6035-05

Device Problem Osseointegration Problem (3003)

Patient Problem Failure of Implant (1924)

Event Date 05/18/2022

Event Type  Injury  

Manufacturer Narrative

Patient weight and bone quality are unknown.Explant date is unknown.Lot information is unknown.If additional information becomes available a supplementary report will be submitted.The implant failure modes, failure/ loss of osseo-integration and lack of primary stability are not product related and rather are attributed to patient contraindications, conditions, or clinician error in surgical protocol.No product investigation or corrective actions required.Complaints will continue to be trended.

Event Description

Per complaint (b)(4), during clinical procedure, patient experienced loss of implant to osseointegrate.

• Brand Name: REPLANT IMPLANT CLOSED-TRAY TRANSFER
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: sergio alvarado ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8057785975
• MDR Report Key: 17727479
• MDR Text Key: 323146124
• Report Number: 3001617766-2023-03866
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307121237
• UDI-Public: 10841307121237
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 09/12/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6035-05
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female