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	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Per complaint (b)(4), during clinical procedure, broken or fractured component was observed.
Additional 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
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 11087759
• Report Number: 3001617766-2020-09135
• Device Sequence Number: 3786512
• Product Code: NDP
• UDI-Device Identifier: 10841307119210
• UDI-Public: 10841307119210
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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 faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1