Description of Event or Problem · 1
IT WAS REPORTED TO DEPUY ACROMED THAT 2 VSP SCREWS BROKE POST-OPERATIVELY (BETWEEN 6 MONTHS TO TWO YEARS POST-OPERATIVELY) IN TWO DIFFERENT PATIENTS. THEY REMAIN INPLANTED AND THE SURGEON WAS NOT CONCERNED. THIS WAS MENTIONED TO A DEPUY ACROMED SALES REPRESENTATIVE IN A CONVERSATION WITH THE SURGEON. NO FURTHER INFORMATION WAS REPORTED. AN INVESTIGATION OF THE PRODUCT COMPLAINT WAS NOT POSSIBLE. A RECORD REVIEW COULD NOT BE PERFORMED SINCE THE LOT INFORMATION WAS NOT PROVIDED. A DEFINITIVE CAUSE OF THE EVENTS CANNOT BE DETERMINED. THE LABELING CONTAINED WITH THE PRODUCT WARNS THAT "SPINAL IMPLANTS, LIKE ANY OTHER TEMPORARY INTERNAL FIXATION DEVICES, HAVE A FINITE USEFUL LIFE...BECAUSE OF THE LIMITATIONS IMPOSED BY ANATOMIC CONSIDERATIONS AND MODERN SURGICAL MATERIAL, METALLIC IMPLANTS CANNOT BE MADE TO LAST INDEFINITELY." THE TIME FRAMES MENTIONED BY THE SURGEON (6 MONTHS, 2 YEARS) INDICATE THAT THE SCREWS MOST LIKELY BROKE BECAUSE THEY EXCEEDED THEIR FINITE USEFUL LIFE. NO FURTHER ACTION CAN BE TAKEN AT THIS TIME.