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

Catalog Number 8035-15

Device Problem Failure to Osseointegrate (1863)

Patient Problems Failure of Implant (1924); Osteopenia/ Osteoporosis (2651)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

Patient's weight was not provided.When the requested information becomes available, a supplementary report will be submitted.Device evaluation results are not available.When the analysis is complete, a supplemental report will be submitted.

Event Description

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

Manufacturer Narrative

Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d4 for catalog # and unique identifier (udi) #.Updated g1 for follow-up report submitter, g3 for awareness date and g6 for report type and follow-up number.Updated h2 for follow-up type, h3 for device evaluation status and h6 method, result and conclusion codes.Device received is different from the part that was indicated on the initial 3500a report.Lot number and manufacture/expiration dates previously submitted do not apply.Lot number information is unknown.

• Brand Name: LEGACY HEALING COLLAR
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 11893488
• MDR Text Key: 252915075
• Report Number: 3001617766-2021-03093
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307111306
• UDI-Public: 10841307111306
• Combination Product (y/n): N
• PMA/PMN Number: K061319
• 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: 06/22/2021

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 Expiration Date: 04/29/2024
• Device Catalogue Number: 8035-15
• Device Lot Number: 139748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 05/25/2021
• Supplement Dates FDA Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR