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

Catalog Number 8035-22

Device Problem Loss of Osseointegration (2408)

Patient Problems Failure of Implant (1924); Inflammation (1932)

Event Date 03/23/2022

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.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), during clinical procedure, patient experienced loss or failure of implant to integrate.

• Brand Name: LEGACY STRAIGHT 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: 14074539
• MDR Text Key: 289001374
• Report Number: 3001617766-2022-01805
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307111719
• UDI-Public: 10841307111719
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8035-22
• Device Lot Number: 150908
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2019
• 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: 48 YR
• Patient Sex: Male