This part is not approved for use in the us, however a like device with part# (b)(4), 510k# k090740 and upn (b)(4) is approved for sale.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.
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Pre-op diagnosis: l4 burst fracture procedure: l4: vertebroplasty; l3-5: posterior fusion it was reported that post-op, ct exam revealed screw malposition at l5.Patient suffered with low back pain, lower extremity pain and muscle weakness as a result and underwent a revision on (b)(6) 2017 to adjust the positions of the screws.
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Although it is unknown which of the devices led to the event, however, we are filing this report for notification purposes.Following devices were involved: part# lot# qty similar device 510k# upn 0350269w, 1, 83565459, k090740, (b)(4), gx83565459; 490544w, 2, 83565459, k090740, (b)(4), gx83565459; 0361972w, 1, 83565459, k090740, (b)(4).If information is provided in the future, a supplemental report will be issued.
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