WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.5MM TI CANC LOCK SCRW 51MM THRD LGTH; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
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Model Number 489.171 |
Device Problems
Material Integrity Problem (2978); No Apparent Adverse Event (3189)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Manufacturer Narrative
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Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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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Event Description
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It was reported that on an unknown date, the surgeon performed an l2 lateral corpectomy with supplemental plate fixation from l1-l3 with depuy synthes tslp lateral plate on (b)(6) 2021.The surgeon got x-rays in (b)(6) 2022 showing the expandable cage had subsided into the l1 vertebral body with one of the screws from the tlsp plate in l1 body broken at the neck of the screw close to the screw/plate interface.The patient was stable with no clinical issues.The patient had experienced a post-op device malfunction this report is for one (1) 5.5mm ti canc lock scrw 51mm thrd lgth.This is report 4 of 5 for complaint (b)(4).
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Event Description
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The initial complaint was reviewed and found not reportable.There is no allegation against this device and the reported information does not reasonably suggest that the device may have caused or contributed to a serious injury.
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Search Alerts/Recalls
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