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

Catalog Number GS-3.4

Device Problem Separation Failure (2547)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2023

Event Type  Injury  

Manufacturer Narrative

Explant date is unknown.Device evaluation results are not available.If the analysis is complete, a supplemental report will be submitted.

Event Description

Per complaint (b)(4), during clinical procedure, components could not be separated.

• Brand Name: GUIDED SURGERY HANDLE INSERT 3.4MMD
• Type of Device: 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: 16704950
• MDR Text Key: 312932966
• Report Number: 3001617766-2023-01510
• Device Sequence Number: 1
• Product Code: NDP
• UDI-Device Identifier: 10841307122609
• UDI-Public: 10841307122609
• 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
• Report Date: 04/07/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2023
• Device Catalogue Number: GS-3.4
• Device Lot Number: 127063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2018
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 86 KG