MEDOS INTERNATIONAL SÃ RL CH VIPER TI SAI POLY 9X90MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Model Number 179704990 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4) the device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation 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 on (b)(6) 2019, the patient underwent revision surgery due to the rod that was broken bilaterally and the distal screws were loosened.Broken ends of rod catalog # 1797-62-480, verse screw, 1997-21-750 x qty 1, verse screw 1997-21-745 x qty 1 and 9.0x90mm sai screws 1797-04-990 x qty 2 were all removed to revise.A 12.0x100mm screw, 1797-12-399 was removed with pliers due to the first of two screwdriver tips breaking.This screw was not recovered to return.There were no fragments generated.It is unknown if there were surgical delay.The patient and procedure outcome was unknown.This complaint involves six (6) devices.
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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 could not be performed as the lot number is unknown.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.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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