MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS, LLC UP-ANGLED MICROPITUITARY; RONGEUR

Model Number ML44911

Device Problems Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2015

Event Type  malfunction  

Event Description

During right microlumbar diskectomy, the aesculap upgoing micropituitary was inserted into disc space at l5-s1.Upon removal, it was noted that the "upper jaw" of the micropituitary was missing.Unable to locate missing piece.Fluoroscopy was performed to confirm missing jaw not in surgical field or patient.Surgery was successfully completed with no injury to patient.

• Brand Name: UP-ANGLED MICROPITUITARY
• Type of Device: RONGEUR
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS, LLC; 3773 corporate parkway; center valley PA 18034
• MDR Report Key: 5013133
• MDR Text Key: 23395937
• Report Number: 5013133
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: ML44911
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 34 YR
• Patient Weight: 87