THIS PRODUCT IS NOT MARKETED IN US BUT A SIMILAR DEVICE WITH CATALOG # 853-465, UDI# (B)(4) AND 510K# K050082 IS APPROVED FOR SALE IN US. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: (PRODUCT ID: (B)(4), LOT: 0567631W, QTY: 8). ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
D
Patient 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT LAMINOPLASTY AT C5-C6 DUE TO SPONDYLOTIC MYELOPATHY. POST-OP, THE HINGE (PATIENT'S BODY PART) SIDE OF BOTH C5 AND C6 FRACTURED AND AS A RESULT THE IMPLANTED SCREWS DROPPED INTO THE SPINAL CANAL. PATIENT UNDERWENT REVISION SURGERY FOR REMOVING THE SCREW AND ALSO UNDERWENT POSTERIOR SPINAL FUSION (PSF) SURGERY AT C4-C7 DUE TO KYPHOSIS PROGRESS. THERE WAS NO DEFECTS ON THE IMPLANTS.
N
Patient 1
ADDITIONAL INFORMATION: X-RAY REVIEW RESULT: C5-6 LAMINOPLASTY POST-OP X-RAY AND CT IMAGES WERE PROVIDED. THERE IS A FRACTURE OF THE NON INSTRUMENTED SIDE OF THE LAMINOPLASTY AND TO NOT SEE A SCREW IN THE SPINAL CORD ON THE PROVIDED IMAGES. LIKELY CAUSE OF HARDWARE FRACTURE IS PROGRESSION OF DEFORMITY IN THE CONSTRUCT WHERE FUSION IS NOT EXPECTED TO OCCUR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.