DEPUY-SYNTHES SPINE CARBON-FIBER COMPOSITE, PARALLEL, 0°, 9X10X23MM; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
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Catalog Number 187823110 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Failure of Implant (1924)
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Event Date 05/17/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The two (2) concorde bullet 9x10x23 parallel cages [product code: 1878-23-110] were not returned to the customer quality unit (cqu) for evaluation.As a result, an investigation will be based on a no sample device evaluation.Should more information and/or the device samples become available at a later date, this complaint file will be reopened and the samples will then receive a full evaluation.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.Without the returned of the device, we are unable to confirm the reported issue or identify the root cause.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device remains implanted in patient.
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Event Description
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The reported products were used in the original surgery for both ¿spinal canal stenosis¿ and ¿l4-l5 separated spondylolisthesis¿, stabilizing l3-l5, on (b)(6) 2017.After the initial surgery, it was found that the reported two cages ¿conc bullet parallel 9x10x23 (187823110)¿ had become backed out toward the spinal canal.Current treatment status: since any neurological symptom hasn¿t appeared, further surgery is not planned.So the (b)(6)-year-old female patient has been under observation.
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