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 Known Impact Or Consequence To Patient (2692)
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Event Date 04/23/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4), unknown.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 posterior spine fusion surgery was performed on (b)(6) 2019 due to thoracic lumbar spinal canal stenosis after olif to fix th9/sai with expedium system.In order to do the reinforcement of fixation, the surgeon choose double rod technique with re bend rod and universal connector (p/n: 179771555) from lumbar to sai.However, the surgeon felt strange feeling when the surgeon performed final tightening of the set screw, so that the surgeon removed the set screw.Then, it was reported that the surgeon recognized that the there was a cross thread at the set screw.Thus, the surgeon replaced the set screw and universal connector, and was able to complete the surgery.There was no broken fragment in the patient¿s body.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).Visual examination found that the initial thread on the connector were torn.Noted damage suggests that inadvertently cross threading of the setscrew occurred upon insertion into the tulip head of the connector.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 on the conn o/o sd top ntch 5.5x5.5 t cannot be determined.Noted damage suggests that inadvertently cross threading of the setscrew occurred upon insertion into the tulip head of the connector.It should be noted that tightening the setscrew when it is cross threaded places force on the setscrew and the tulip head¿s threads that can result in them being torn.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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