MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SCREWINDIRECT IMPLANT; DENTAL IMPLANT

Catalog Number 404713

Device Problems Inadequacy of Device Shape and/or Size (1583); Failure to Osseointegrate (1863)

Patient Problem Failure of Implant (1924)

Event Date 02/08/2021

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), after clinical procedure, patient experienced failure of implant to osseointegrate.

Manufacturer Narrative

Updated b4 for report submission date, g1 for contact information, g3 for awareness date of new information, g6 for report type and sections d9, h1, h2, h3, and h6 to report that the device was not received for analysis.

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: SCREWINDIRECT IMPLANT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 11877227
• MDR Text Key: 252413634
• Report Number: 3001617766-2021-03019
• Device Sequence Number: 1
• Product Code: DZE
• UDI-Device Identifier: 10841307104834
• UDI-Public: 10841307104834
• 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,Followup
• Report Date: 07/26/2021

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 Catalogue Number: 404713
• Device Lot Number: 167069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 06/04/2021; 07/08/2021
• Supplement Dates FDA Received: 06/22/2021; 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 71