MAUDE Adverse Event Report: STRYKER CORPORATION TRITANIUM CAGE; INTERBODY CAGE

Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/19/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
During a routine complex spine surgery, an l2-l3 transforaminal lumbar interbody fusion, i elected to use a stryker corporation ((b)(4)) "tritanium" inter body device ("cage"), 28 mm length, 11 mm in height and 6 degrees of lordosis.Using standard surgical technique, i inserted the inter body device into the prepared l2-l3 disc space.The initial 50% of insertion was by manual pushing, and the final 50% of insertion by gentle tapping on the back end of the inserter device with a mallet.Once in place, a fluoroscopic image was taken, that demonstrated an abnormal slight obliquity to the device.Upon inspection, i discovered that the proximal (i.E., portion nearest the junction with the inserter) one third of the implant had separated (fractured) from the rest of the implant, and other parts of the implant had simply crumbled.Because of this failure, i needed to then remove the fragments of the inter body cage from the disk space using chisels and graspers.No visible injury occurred to the pt as a result of the device failure.I completed the procedure without incident with an inter body device from a different mfr.I collected the device fragments and had them sent back to stryker corporation.Upon inquiring about this failure with stryker reps later that day, i was informed that stryker is aware of over 20 cases where a tritanium implant has fractured into pieces during surgical implantation.Obviously i find this extremely alarming as a tritanium inter body implant should not break into pieces during insertion, and it furthermore makes me very concerned whether such tritanium devices will remain functional and in one pieces when subjected to constant loading cycles in an upright and ambulating pt.

• Brand Name: TRITANIUM CAGE
• Common Device Name: INTERBODY CAGE
• Manufacturer (Section D): STRYKER CORPORATION; kalamazoo MI
• MDR Report Key: 7302522
• Report Number: MW5075574
• Device Sequence Number: 12270722
• Product Code: MAX
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/27/2018
• 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
• Patient Age: 68 YR
• Patient Weight: 118