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

Catalog Number 9048-20

Device Problem Loss of Osseointegration (2408)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 04/06/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluation results are not available.When the analysis is complete, a supplemental report will be submitted.

Event Description

Per complaint (b)(4), patient experienced loss or failure of implant to integrate.

Manufacturer Narrative

Updated b4 for report submission date, g1 for contact information, g3 for awareness date of new information, g6 for report type and h6 to report that the device was not received for analysis.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.

• Brand Name: SWISH STRAIGHT ABUTMENT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 10989966
• MDR Text Key: 220887574
• Report Number: 3001617766-2020-08681
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 10841307116547
• UDI-Public: 10841307116547
• Combination Product (y/n): N
• PMA/PMN Number: K090234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/13/2022
• Device Catalogue Number: 9048-20
• Device Lot Number: 105083
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 73