MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC SPECTRA-SYSTEM/ LEGACY GUIDED SURGERY HANDLE KIT; DENTAL IMPLANT

Catalog Number G-HK

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Patient's identifier, age, weight, date of event, other relevant history, including preexisting medical conditions, implant and explant date were not provided.When the requested information becomes available, a supplementary report will be submitted.Device evaluation results are not available.When the analysis is complete, a supplemental report will be submitted.

Event Description

Per complaint (b)(4), during clinical procedure, broken or fractured component 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 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.This complaint is being submitted late due to the furloughs that resulted from the global pandemic and is captured within deviation 1412.

• Brand Name: SPECTRA-SYSTEM/ LEGACY GUIDED SURGERY HANDLE KIT
• Type of Device: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 11087759
• MDR Text Key: 224131250
• Report Number: 3001617766-2020-09135
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119210
• UDI-Public: 10841307119210
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2019
• Device Catalogue Number: G-HK
• Device Lot Number: 52987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/06/2021
• Supplement Dates FDA Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1