DEPUY SYNTHES SPINE EXPEDIUM VERSE; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Model Number 199723740 |
Device Problem
Torn Material (3024)
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Patient Problems
Fall (1848); Failure of Implant (1924); Injury (2348)
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Event Date 09/06/2017 |
Event Type
Injury
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Manufacturer Narrative
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A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Not returned for evaluation.
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Event Description
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L5/s1 spondylolithesis correction with l5/s1 tlif and plf.Previous l5/s1 tlif for spondylolithesis reduction 28.8.2017.Reduced well initially.Patient fell after discharge from hospital and had l5 screw pull bilaterally.Revision procedure to replace l5 screws and further decompress l5 nerve root for post event radiculopathy.Replaced l5 (6x40mm verse) screws with 7x40mm verse screws.Tried to re-reduce the spondylolithesis using the verse tabs using correction keys.Correction keys cross threaded in l5 screw tabs.This continued for 5 correction keys.Used the quick stick alignment guides to try and prevent cross threading.The right 7x40mm screw thread stripped.The surgeon removed the tabs and used the verse threaded reduction tool for the spondy reduction.At this point the thread in the head of the right 7x40mm screw in l5 stripped away from the tulip and had to be picked out of the operative sight with forceps.This screw had partially pulled out of the pedicle and was removed and replaced with an 8x40mm screw.Tabs were removed, reduction tool was used bilaterally, slip reduced, unitized set screws used instead of correction keys.No cross threading this time.Final torque off and close.Procedure delayed by 60 minutes.Additional complaint received for same patient same procedure: l5/s1 spondylolithesis correction with l5/s1`tlif and plf.Previous l5/s1 tlif for spondylolithesis reduction ((b)(6) 2017).Reduced well initially.Patient fell after discharge from hospital and had l5 screw pull out bilaterally.Revision procedure (b)(6) 0217 to replace l5 screws and further decompress l5 nerve root for post event radiculopathy.Replaced l5 (6x40mm verse) screws with 7x40mm verse screws.Case is linked to (b)(4) - issues that occurred during the revision procedure.
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Manufacturer Narrative
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Visual examination of the returned device found the threads were torn.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause cannot be determined with the information provided.A potential root cause could be due to inadvertently cross-threading during insertion.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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