DEPUY SPINE INC CONN O/O SD TOP NTCH 5.5X5.5 T; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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Model Number 179771555 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/22/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 the reinforcement surgery was performed on (b)(6) 2018 to reinforce the implanted rod at lumber.During the surgery, it was reported that the screw thread was broken (peeled off) when the surgeon tightened the reported set screw the reported universal connector.The surgery was finished without any other problem although it was not reported how the surgery was completed.There was less than 30min.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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(b)(4).
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Manufacturer Narrative
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(b)(4).Visual examination found that the initial threads on the connector tulip head are torn.The threads on the set screw are torn in the connector tulip 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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.With the information provided, a definitive root cause for the torn threads on the connector tulip head cannot be determined.Noted damage suggests that inadvertently cross threading of the setscrew occurred upon insertion into the connector 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 and no systemic trends were found, 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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