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

Catalog Number 8035-62

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Impaired Healing (2378)

Event Date 03/04/2022

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.

Event Description

Per complaint 80382, during clinical procedure, product fracture was observed.

Manufacturer Narrative

Follow-up submitted to report device evaluation.Updated section b4 for report submission date and b6 to report device evaluation results.Updated d9 for device return date, 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.

• Brand Name: LEGACY OVERDENTURE ABUTMENT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: karen manalili ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8057785914
• MDR Report Key: 13976711
• MDR Text Key: 288374301
• Report Number: 3001617766-2022-01653
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307111498
• UDI-Public: 10841307111498
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K090234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2022
• Device Catalogue Number: 8035-62
• Device Lot Number: 89483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2017
• 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: 57 YR
• Patient Sex: Male