MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY IMPLANT ANALOG; DENTAL IMPLANT

Catalog Number 8530-06D

Device Problem Osseointegration Problem (3003)

Patient Problem Failure of Implant (1924)

Event Date 07/06/2021

Event Type  Injury  

Manufacturer Narrative

Patient's identifier and explant date were not provided.If the requested information becomes available, a supplementary report will be submitted.Patient weight is unknown.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.

Event Description

Per (b)(4), during clinical procedure, error in surgical protocol.

Manufacturer Narrative

Updated b4 for report submission date, g1 for contact information, g3 for awareness date of new information, g6 for report type and sections d9, h1, h2, h3, and h6 to report that the device was not received for analysis.

• Brand Name: LEGACY IMPLANT ANALOG
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 12158740
• MDR Text Key: 261237552
• Report Number: 3001617766-2021-04104
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: 872.398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8530-06D
• Device Lot Number: 182592
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR