DEPUY SPINE INC EXP 4.5 TI SINGLE INNIE; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Model Number 186100001 |
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 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 an unknown date, during lengthening of prior growing rod construct, the rod would not stay in the open saddle of the connector because the set screws would strip out and fail.He felt the cobalt chrome (cocr) rod needed to be contoured so it would lay in the connector saddle without resistance when placing a set screw.There was a 20-30 minutes surgical delay, procedure outcome was unknown.There was patient harm/consequence.This complaint involves six (6) devices.
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Manufacturer Narrative
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Product complaint (b)(4).Udi (b)(4).Visual examination found that the threads on the set screw were completely torn off.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.With the information provided, a definitive root cause for the torn threads cannot be determined.Noted damage suggests that inadvertently cross threading of the setscrew occurred upon insertion into the tulip head.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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Search Alerts/Recalls
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