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

Catalog Number	G-HK
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/22/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Per complaint (b)(4), during clinical procedure, deformation was observed.

• Brand Name: SPECTRA-SYSTEM/ LEGACY GUIDED SURGERY HANDLE KIT
• Common Device Name: 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
• Report Number: 3001617766-2021-07061
• Device Sequence Number: 4963044
• Product Code: NDP
• UDI-Device Identifier: 10841307119210
• UDI-Public: 10841307119210
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: G-HK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 01/31/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male