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

Catalog Number 6534-63-30S

Device Problem Loss of Osseointegration (2408)

Patient Problem Failure of Implant (1924)

Event Date 10/07/2022

Event Type  Injury  

Manufacturer Narrative

Patient's weight was not provided.If the requested 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), after clinical procedure, patient experienced loss of implant to osseointegrate.

• Brand Name: INTERACTIVE ANGLED 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: marcos gutierrez ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8184443315
• MDR Report Key: 15913393
• MDR Text Key: 304777932
• Report Number: 3001617766-2022-05961
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307109457
• UDI-Public: 10841307109457
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130572
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6534-63-30S
• Device Lot Number: 181588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2021
• 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: 60 YR
• Patient Sex: Female