MEDOS INTERNATIONAL SÃ RL CH MNTR F/A SCREW 4.0 DIA X 24; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
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Model Number 188318424 |
Device Problem
Disconnection (1171)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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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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After putting a pedicle screw the surgeon noticed that the screw head loosened.Was surgery delayed due to the reported event?: unknown.Was procedure successfully completed?: unknown.Were fragments generated?: unknown.If yes, were they removed easily without additional intervention?: unknown.Patient status/ outcome / consequences: no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown.Is the patient part of a clinical study: unknown.By checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.True.
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Manufacturer Narrative
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Product complaint #: (b)(4).
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Manufacturer Narrative
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Product complaint # (b)(4).The returned device was received assembled with no obvious damage to the screw threads or the screw head.The screw and screw head both showed signs of wear.The drag spring (ring) component appeared to be deformed and did not sit flush in the screw.Upon disassembly, it appeared that the screw head cap component was missing from the screw head.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.Although no definitive root cause could be determined for the missing component, it is possible that the device experienced unintended forces which lead to the disassembly of the screw head cap.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, this complaint file will be closed with no further action required.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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