MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON SPINAL SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL
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Model Number 5540030 |
Device Problems
Device Slipped (1584); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient who was implanted with a spinal product type for lumbar disc herniation.It was reported that during the operation, one of the screw plug slipped, and the other screw was locked and the universal head lost its function when it was about to open.There was screw damage.No patient symptoms or complications as a result of this event.There was no device breakage.Product utilized correctly according to the directions given in the ifu/labeling.Additional information received on (b)(6) 2021 reported that self-breaking screw slipped.The other was a universal screw, the angle of the universal was gone, and it was stuck.There was a certain delay, and the time for replacing screw and screw plug was 5-10 minutes.
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Manufacturer Narrative
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Product analysis product id:5540030 lot# h5605621 visual and macroscopic inspection confirmed the threads of the set screw have been damaged.The thread crest and flank damage appears to have initiated at the start of the thread, and is consistent around the damaged portion of the thread.The female torx of the screw has not been damaged.The break off portion of the set screw is still attached.This type of damage is consistent with misalignment of the set screw threads during construct assembly.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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