On (b)(6) 2023, a female patient underwent an anterior lumbar interbody fusion procedure.After the surgeon implanted the spacer into the patient, it was noted the distal tip of the inserter broke off.All pieces were retrieved.There were no patient symptoms or complications reported as result of this event.(this is report 2 of 2).
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Additional information: h3.Yes.Corrected information: h6.Investigation findings: 3251.Investigation conclusion: 22.H10.Visual inspection of the device confirmed the distal arm had detached and separated from the shaft.The distal arm did not return with the device.There is no report of the arm remaining in the patient.The arm of the inserter is a subcomponent which features an ipsilateral prong that attaches to the interbody spacer for insertion.This type of damage is consistent when force is applied during impaction/insertion of the interbody spacer causing the distal arm to detach from the shaft.Labeling review: "warnings/cautions/precautions: potential risks identified with the use of these fusion devices, which may require additional surgery, include device component failure, loss of fixation, pseudoarthrosis (i.E., non-union), fracture of the vertebra, neurological injury, and/or vascular or visceral injury." "possible adverse effects: possible adverse effects include: 1.Initial or delayed loosening, bending, dislocation, and/or breakage of device components.".
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