MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL
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Catalog Number 55840007545 |
Device Problems
Break (1069); Component Missing (2306)
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Patient Problems
Failure of Implant (1924); Post Operative Wound Infection (2446); Device Embedded In Tissue or Plaque (3165)
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Event Type
Injury
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Manufacturer Narrative
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Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Pre-op mri and post-op x-rays for l5-s1 fusion shows there is minimal pre-op listhesis and post-op hardware placement appears appropriate.It was difficult to see a broken screw on provided images, but given time for surgery, presumably fusion had not occurred.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient underwent l5-s1 fusion surgery in (b)(6) 2017 for an olisthesis syndrome.Post-op, screw breakage and some cartilage was reported in the wound around l5-s1.The broken, missing front part of the screw was left in the patient.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: product analysis - visual examination of the mas bone screw confirmed bone screw complete fracture at approximately ~5 threads from the base of the bone screw head.Visual examination did not identify material defect near the area of fracture origin, which could contribute to crack propagation.Microscopic examination of the fracture surface identified gently curving convex striations through the cross-sectional area of the implant, which are indicative of cyclic fatigue until subsequent mechanical failure of the implant.The above observations are consistent with cyclic fatigue.Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated if information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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