SYNTHES GMBH 3.5MM TI CANCELLOUS POLYAXIAL SCREW 28MM FOR 4.0MM RODS; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
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Catalog Number 04.615.028S |
Device Problem
Mechanical Problem (1384)
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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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Manufacturer Narrative
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Additional device product codes: mni, nkg, and kwp.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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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, a patient¿s rod broke, and a screw was loose.In (b)(6) 2018 a posterior cervical fusion was performed on the patient at o-c4.On an unknown date, the patient turned over in bed and heard cracking noise from the cervical area.On (b)(6) 2021 the patient went to see the surgeon, and it was found by ct, that the rod had broken off and the screw was loose.The patient has suffered from paralysis in the limbs since the event.On (b)(6) 2021 the patient is scheduled to undergo a revision procedure for rod replacement and screw-application-range extension.The surgeon evaluated the event¿s severity as ¿mild to moderate.¿ this report involves one (1) 3.5mm ti cancellous polyaxial screw 28mm for 4.0mm rods.This is report 2 of 6 for (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.H3, h4, h6- product complaint # (b)(4).Investigation summary = product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot =manufacturing location: brandywine / packaged and released by: monument release date: 09-mar-2018, expiration date: 01-mar-2028, part number: 04.615.028s, 3.5mm ti cancellous polyaxial screw 28mm for 4.0mm rod (sterile), lot number: h575306.This lot met all visual, sterilization and packaging criteria at the time of release with no issues documented during the packaging or release of the product that would contribute to this complaint condition.Device history review = 02-apr-2021: dhr reviewed by: (b)(4).This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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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