LOQTEQ® BROAD PLATE 4.5, 16 HOLES, L 293

Description of Event or Problem

AN OSTEOSYNTHESIS PLATE FRACTURED APPROXIMATELY 5 MONTHS AFTER IMPLANTATION IN THE ABSENCE OF FRACTURE HEALING.

Additional Manufacturer Narrative

COMPLIANCE WITH THE KNOWN RULES OF OSTEOSYNTHESIS, WHICH MUST BE CONSIDERED AS A BASIS FOR THE USE OF THE PLATE SYSTEM, DID NOT OCCUR. THE FOLLOWING RULE WERE NOT OBSERVED: TWO CRITERIA ARE USED WHEN SELECTING THE LENGTH OF LOCKING PLATES: WORKING LENGTH AND TOTAL LENGTH. THE WORKING LENGTH IS THE DISTANCE BETWEEN THE FIRST TWO LOCKING SCREWS LOCATED ON EITHER SIDE OF THE FRACTURE SITE. THIS IS THE AREA ON WHICH THE STRESSES ACT. IT DETERMINES THE STIFFNESS OF THE CONSTRUCT. THE CONSTRUCT MUST BE STIFF AND AT THE SAME TIME ELASTIC TO ALLOW THE MICRO-MOVEMENT NECESSARY FOR HEALING. IN A FRACTURE, LEAVING THREE OR FOUR EMPTY HOLES OVER THE FRACTURE SITE WILL RESULT IN THE DESIRED ELASTICITY OF THE CONSTRUCT. THIS WAS NOT THE CASE IN THE PRESENT CASE. AN IMPLANT-BASED CAUSE COULD NOT BE PROVEN.