MEDOS INTERNATIONAL SÃ RL CH UNK - SCREWS: VIPER PRIME; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
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Device Problem
Device Slipped (1584)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient underwent a primary fusion procedure (l3/4/5).On (b)(6) 2018 the patient underwent the 1st revision procedure, extension fusion.The unknown screws at l3/4 were removed.They used the viper prime 7.0mm-50mm screw in question as a replacement at l5.Also, an additional screw was deployed in the ilium.On an unknown date it was found that the viper prime screw at l5 had been loose.This report involves one (1) screws: viper prime.This is report 2 of 2 for (b)(4).This product complaint,(b)(4), is related to (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown screws: viper prime/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.(b)(4).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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