MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACT LEGACY HEALING COLLAR 4.5MMD PLAT 5MML; COMPONENT

Catalog Number	8045-15
Medical Device Problem Codes	Positioning Failure (1158); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Part not functional.

• Brand Name: LEGACY HEALING COLLAR 4.5MMD PLAT 5MML
• Common Device Name: COMPONENT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACT; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer (Section G): IMPLANT DIRECT SYBRON MANUFACT; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: anitha mechery ; 3050 east hillcrest drive; thousand oaks 91362 ; 8057785975
• MDR Report Key: 23928110
• Report Number: 3001617766-2025-009529
• Device Sequence Number: 13022035
• Product Code: DZE
• UDI-Device Identifier: 10841307111337
• UDI-Public: (01)10841307111337(10)15028074(17)300730
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K061319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial

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: 8045-15
• Device Lot Number: 15028074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/31/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR
• Patient Sex: Female