MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CALIBER; CALIBER SPACER 10 X 26MM, 9-13MM

Model Number	194.426
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Spinal Cord Injury (2432)
Date of Event	09/21/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
This report is being resubmitted for an incident that occurred earlier.He implant and instruments were not returned for evaluation.The following sections have been updated: b4, e1, e3, h2, h6, h10.
Event or Problem Description
A revision surgery was performed to remove implants at l5-s1 and extend the construct to l4-l5 with bilateral caliber spacers at l4-5.It was determined through final intraoperative x-ray that the caliber spacer implanted on the patient's right was positioned too far anterior.Attempts were made to remove and pull back the implant; however, this caused the spacer to advance further anteriorly.The patient experienced significant blood loss and was flipped supine and received vascular intervention.The patient passed away.

• Brand Name: CALIBER
• Common Device Name: CALIBER SPACER 10 X 26MM, 9-13MM
• Manufacturer (Section D): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer (Section G): GLOBUS MEDICAL, INC.; 2560 general armistead avenue; audubon PA 19403
• Manufacturer Contact: daniel paul ; 2560 general armistead avenue; audubon, PA 19403 ; 6109301800
• MDR Report Key: 18826501
• Report Number: 3004142400-2018-00047
• Device Sequence Number: 19569430
• Product Code: MAX
• UDI-Device Identifier: 00849044020298
• UDI-Public: 00849044020298
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K102293
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

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 Model Number: 194.426
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Death
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Race: White