Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.This device is not approved for sale in us but a similar device with catalog # 1556200500, 510k# k131321 and udi (b)(4) is approved for sale in us.This event is serious injury reportable.Since the device is not marketed in the us, the device is reported as a malfunction for a similar device.If information is provided in the future, a supplemental report will be issued.
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Information was received from the healthcare provider (hcp) via the manufacturer representative regarding an event which occurred post an initial t9/s2 psf l2/3 plif l4 pso procedures in a patient diagnosed with lumbar kyphosis.It was reported that the products explanted due to postoperative transverse process fracture.The hooks on both sides used for the t9 transverse process were removed.There was no malfunction with the hooks themselves.The cranial rods were too long and could almost be touched through the skin, so the rods were cut.There are no reports of defects or adverse events for the rod.Doctor cut 50 cm rods and use them, so there is no problem with the size of the rod as a product.It seems to be a problem when installing.The doctor intentionally cut a rod that was too long during the reoperation.No other patient injury / complication was reported.
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