Product complaint # = > (b)(4).Udi: ((b)(4).Visual examination of the setscrew revealed signs of operative use as evidence by superficial markings.Weak, lopsided rod striations were observed on the set screw suggesting that the set screw was not seated properly.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.A definitive root cause for the set screw becoming loose cannot be positively determined.However, the weak, lopsided rod striations observed on the set screw suggests that the set screw were not properly tightened on to the rod, resulting in the set screw becoming loose.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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