MAUDE Adverse Event Report: SPINAL ELEMENTS SPINE CAGES; SPINAL DEVICES

Device Problems Crack (1135); Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2018

Event Type  No Answer Provided  

Event Description

The surgeon had issues fitting the spine cage and used manipulation methods to fit it.He then decided to use another sized cage and used the cage he had tried to fit in another area.On inspection of the spinal cage, it was noted to have cracks in it.The surgeon felt these cracks would not compromise the cage itself and implanted it in the patient.Dates of use: (b)(6) 2018.Diagnosis or reason for use: lumbar/spinal surgery.

• Brand Name: SPINE CAGES
• Type of Device: SPINAL DEVICES
• Manufacturer (Section D): SPINAL ELEMENTS; marietta GA 30062
• MDR Report Key: 7366038
• MDR Text Key: 103412908
• Report Number: MW5076049
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 78