7.0MM TI SIDE-OPENING SCREW 45MM

Description of Event or Problem

CONSULTANT REPORTED PATIENT WAS IMPLANTED WITH SYNTHES UNIVERSAL SPINE SYSTEM (SYNTHES USS) FOR AN L4-L5 POSTERIOR FUSION ON AN UNKNOWN DATE IN (B)(6) 2012. THE PATIENT RETURNED TO THE SURGEON ON AN UNKNOWN DATE COMPLAINING OF EXPERIENCING BACK PAIN. THE SURGEON DETERMINED THAT THE PATIENT HAD ADJACENT LEVEL STENOSIS AT L3-L4 LEVEL IN ADDITION TO A NON-UNION AT L4-L5. THERE WERE NO ISSUES WITH THE HARDWARE. ON (B)(6) 2013, SURGEON RETURNED THE PATIENT TO THE OPERATING ROOM AND REMOVED ALL THE SYNTHES UNIVERSAL SPINE SYSTEM HARDWARE, AND RE-INSTRUMENTED THE PATIENT WITH NEW SYNTHES UNIVERSAL SPINE SYSTEM HARDWARE AT THE L4-L5 LEVEL AND PLACED SCREWS AT L3. HE PERFORMED A DECOMPRESSION AT THE L3-L4 LEVEL AND PLACED AN MTF TRANSFORAMINAL POSTERIOR LUMBAR INTERBODY FUSION (T-PLIF) ALLOGRAFT AT THAT LEVEL. SURGEON THEN PLACED AND CONNECTED THE RODS FROM L3-L5 AND SUCCESSFULLY COMPLETED THE PROCEDURE. NO REPORT OF DELAY IN SURGERY OR HARM TO PATIENT. NO ADDITIONAL INFORMATION AVAILABLE. THIS IS REPORT 2 OF 14 FOR COMPLAINT (B)(4).

Additional Manufacturer Narrative

THE DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES: MNI, MNH, KWP, KWQ. PART LOT # IS UNKNOWN. DATE RECEIVED BY MANUFACTURER (B)(4) 2013. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WILL BE RETURNED AND NO PART LOT NUMBER IS PROVIDED. PLACEHOLDER.