K2M, INC. DEFORMITY POLYAXIAL SCREW; SIZE Ø6.5X55 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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Model Number 3001-06555 |
Device Problems
Material Separation (1562); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2021 |
Event Type
Injury
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Manufacturer Narrative
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Status and location of the device is currently unknown.
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Event Description
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It was reported that the 'head' of a mesa sm stature deformity polyaxial screw 'popped off' post-operatively.Revision surgery has occurred to replace the screw.
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Event Description
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It was reported that the 'head' of a mesa sm stature deformity polyaxial screw 'popped off' post-operatively.Revision surgery has occurred to replace the screw.
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Manufacturer Narrative
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Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Complaint history records were reviewed for this catalog and no similar complaints were identified.From the ifu: potential adverse events associated with spinal fusion procedures include, but are not limited to pseudoarthrosis; loosening, bending, cracking or fracture of components, or loss of fixation in the bone with possible neurologic damage, usually attributable to pseudoarthrosis, insufficient bone stock, excessive activity or lifting, or one or more of the factors listed in contraindications, or warnings and precautions; infections possibly requiring removal of devices; palpable components, painful bursa, and/or pressure necrosis; and allergies, and other reactions to device materials which, although infrequent, should be considered, tested for (if applicable), and ruled out preoperatively.Internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Loads produced by load bearing and activity levels will impact the longevity of the implant.Metallic implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a bone has healed.If an implant remains implanted after complete healing, it can actually increase the risk of refracture in an active individual.The surgeon should weigh the risks versus benefits when deciding whether to remove the implant.Implant removal should be followed by adequate postoperative management to avoid refracture.Without the device, a definite cause cannot be determined.Based on the length of implantation, pseudoarthrosis or complete healing are possible causes.Additional possible causes from the ifu include insufficient bone stock, excessive activity or lifting, or one or more of the factors listed in contraindications, or warnings and precautions.
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Manufacturer Narrative
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The device has been received and sections d and h have been updated.The screw was returned in 2 pieces with the tulip disengaged from the screw shank.Markings from being implanted were present on the device.Anodization loss on the collet indicates the screw was fully locked.Device history records were reviewed for this lot, no relevant manufacturing issues were identified.Complaint history records were reviewed, no adverse trends were identified.From the ifu: potential adverse events associated with spinal fusion procedures include, but are not limited to pseudoarthrosis; loosening, bending, cracking or fracture of components, or loss of fixation in the bone with possible neurologic damage, usually attributable to pseudoarthrosis, insufficient bone stock, excessive activity or lifting, or one or more of the factors listed in contraindications, or warnings and precautions; infections possibly requiring removal of devices; palpable components, painful bursa, and/or pressure necrosis; and allergies, and other reactions to device materials which, although infrequent, should be considered, tested for (if applicable), and ruled out preoperatively.Internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Loads produced by load bearing and activity levels will impact the longevity of the implant.Metallic implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a bone has healed.If an implant remains implanted after complete healing, it can actually increase the risk of re-fracture in an active individual.The surgeon should weigh the risks versus benefits when deciding whether to remove the implant.Implant removal should be followed by adequate postoperative management to avoid refracture.Based on the duration of implantation, pseudoarthrosis or complete healing are potential causes; however, a definitive root cause cannot be established with the information available.
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Event Description
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It was reported that the 'head' of a mesa sm stature deformity polyaxial screw 'popped off' post-operatively.Revision surgery has occurred to replace the screw.
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Search Alerts/Recalls
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