SYNTHES GMBH CERVIC-SPINE-SCR ø4 DYNAM SELF-DRILL L18; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
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Catalog Number 04.613.518S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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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 japan as follows: it was reported that this was an anterior cervical fusion for opll on (b)(6) 2023.The surgery was completed successfully with no surgical delay.After surgery, there were signs of infection.A ct scan showed something like a wire near the implant.A contrast examination revealed leakage of contrast agent from the esophagus, and a diagnosis of retropharyngeal abscess was made.When the images taken immediately after the surgery were checked again, and a protrusion was confirmed.Antibiotics were used to try to calm down the infection, but the infection was not sedated sufficiently, so a reoperation was performed and a debridement was done.Upon direct visual inspection, a silver wire-like protrusion was confirmed.The silver wire-like protrusion appeared to have been scraped off by interference with the washer part of the plate when the screw was inserted.Only the protruding part was removed with a luer, and the implant itself was not removed.The reoperation was completed successfully with no surgical delay.The surgeon commented as follows: it appears that the screw interfered with the washer part of the plate when it was inserted and was scraped.It is assumed that the scraped part interfered with the esophagus and perforated it, causing the infection to spread.In the past, there was a case where it felt like the washer and screw were interfering with each other, but in that case, the protruding part was removed during the surgery.No further information is available.This report is for one (1) cervic-spine-scr ã¸4 dynam self-drill l18.This is report 4 of 9 for complaint (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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E1:social welfare corporation (b)(6) e3: reporter is a j&j employee.Sterile part: 04.613.518s sterile lot no:142l170, release to warehouse date: 22 feb 2023 expiry date: 01 feb 2033, manufacturing site: werk selzach.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part number: 04.613.518, lot number: 3236p01, manufacturing site: mezzovico.Release to warehouse date: 13 dec 2022.A manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.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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The implants were not explanted.Patient was treated with debridement, but symptoms are unknown.
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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.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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