MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC GUIDED SURGERY HANDLE INSERT 3.4MMD; DENTAL IMPLANT

Catalog Number	GS-3.4
Medical Device Problem Code	Component or Accessory Incompatibility (2897)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implant and explant dates are not applicable due to product was never placed and not removed device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.
Event or Problem Description
Per complaint (b)(4) during clinical procedure, components could not be separated.
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.

• Brand Name: GUIDED SURGERY HANDLE INSERT 3.4MMD
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• Manufacturer Contact: sergio alvarado ; 3050 east hillcrest drive; thousand oaks, CA 91362 ; 8057785975
• MDR Report Key: 16612347
• Report Number: 3001617766-2023-01236
• Device Sequence Number: 6254691
• Product Code: NDP
• UDI-Device Identifier: 10841307122609
• UDI-Public: 10841307122609
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/14/2023

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 Expiration Date: 11/27/2023
• Device Catalogue Number: GS-3.4
• Device Lot Number: 127063
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/09/2023
• Supplement Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2018
• 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 Age: 59 YR
• Patient Sex: Female
• Patient Weight: 82 KG