MEDOS INTERNATIONAL SÃ RL CH VIPER TI SAI POLY 8X80MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Model Number 179704880 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/15/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.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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It was reported that the posterior lumbar fusion surgery was performed to fix th9-s2 on (b)(6) 2019.After the all screws were implanted (reported screw (p/n:179704880) was used for s2), when the surgeon inserted the rod from s2, it was reported that the set screw could not be final tightening so that the surgeon could not inserted to the screw.Then, the surgeon replaced the set screw and attempted for final tightening, but replaced set screw could not be tightened, neither.Finally, the surgeon revised the screw to 8.0mm x 70mm and completed to tighten the set screw.After the surgery, our sales rep checked the condition of reported screw, and found that the thread of the screw head was broken.There was less than 30 min surgical delay and there was no adverse consequence to the patient.No further information was provided by the hospital.
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Manufacturer Narrative
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Product complaint # = > (b)(4).Device was not returned for 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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.Without the return 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.
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