MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC DIRECTGUIDE DRILL EXTENDER; DENTAL IMPLANT

Catalog Number DGDE

Device Problem Separation Failure (2547)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 06/23/2022

Event Type  Injury  

Manufacturer Narrative

Lot information is 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.

Event Description

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

• Brand Name: DIRECTGUIDE DRILL EXTENDER
• 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: 15042206
• MDR Text Key: 296065747
• Report Number: 3001617766-2022-03733
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10841307119111
• UDI-Public: 10841307119111
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081396
• 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: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DGDE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 87 YR
• Patient Sex: Female
• Patient Weight: 82 KG