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

Catalog Number G-HK

Device Problem Osseointegration Problem (3003)

Patient Problem Failure of Implant (1924)

Event Date 11/22/2021

Event Type  Injury  

Manufacturer Narrative

Patient identifier, weight, other relevant history, including preexisting medical conditions were not provided.If the requested information becomes available, a supplementary report will be submitted.Patient age is unknown.Implant date and explant date are not applicable since the product was never placed and not removed.Lot information unknown.If additional information becomes available a supplementary report will be submitted.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.Pma/510(k) - not applicable.

Event Description

Per complaint (b)(4), during clinical procedure, deformation was observed.

• 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
• Manufacturer Contact: karen manalili ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8057785914
• MDR Report Key: 12909083
• MDR Text Key: 281515864
• Report Number: 3001617766-2021-07061
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307119210
• UDI-Public: 10841307119210
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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,Followup
• Report Date: 02/02/2022

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: G-HK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 01/31/2022
• Supplement Dates FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Sex: Male