MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC GUIDED SURGERY HANDLE INSERT 2.3MMD; DENTAL SURGICAL GUIDE SLEEVE

Catalog Number	GS-2.3
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Failure of Implant (1924); No Information (3190)
Date of Event	11/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implant and explant date is unknown.
Event or Problem Description
Per compliant (b)(4), the pilot drill appeared to be stuck inside the guide sleeve.No patient impact was reported.

• Brand Name: GUIDED SURGERY HANDLE INSERT 2.3MMD
• Common Device Name: DENTAL SURGICAL GUIDE SLEEVE
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 9453842
• Report Number: 3001617766-2019-02177
• Device Sequence Number: 2884951
• Product Code: FZX
• UDI-Device Identifier: 10841307122586
• UDI-Public: 10841307122586
• Combination Product (Y/N): N
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 12/11/2019

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: GS-2.3
• Device Lot Number: 143768
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention