The investigation is currently pending, and a follow up report will be submitted upon completion of the investigation.Related reports: 2027754-2022-00062, 2027754-2022-00063, 2027754-2022-00064, 2027754-2022-00065, 2027754-2022-00066, 2027754-2022-00067, 2027754-2022-00068, 2027754-2022-00069, 2027754-2022-00070, 2027754-2022-00071, 2027754-2022-00072, 2027754-2022-00073, 2027754-2022-00074, 2027754-2022-00075, 2027754-2022-00076, 2027754-2022-00077, 2027754-2022-00078, 2027754-2022-00079, 2027754-2022-00080, 2027754-2022-00081, 2027754-2022-00082, 2027754-2022-00083, 2027754-2022-00084, 2027754-2022-00085, 2027754-2022-00086, 2027754-2022-00087, 2027754-2022-00088, 2027754-2022-00089, 2027754-2022-00090, 2027754-2022-00091, 2027754-2022-00092, 2027754-2022-00094, 2027754-2022-00095, 2027754-2022-00096, 2027754-2022-00097, 2027754-2022-00098, 2027754-2022-00099, 2027754-2022-00100, 2027754-2022-00101.
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All aspects of the investigation were reviewed.The concern was reported that "patient might be diagnosed with metallosis (clinical hypothesis) and it could be related to plates and screws implanted".Part numbers and lot numbers were reported and their respective device history records (dhrs) individually reviewed.All lots/products were manufactured according to specification.No discrepancies were found during the dhr review.Devices/products were not returned to the addison facility for further evaluation.A two-year review of complaints were performed, and three other complaints for this issue were noted (complaints reported by the same physician and reported in report numbers 2027754-2022-00102, 2027754-2022-00142, 2027754-2022-00199, and their subsequent/related reports).The literature contains the proper warnings and also specifies product materials.The only known metal reported in the surgical site are the plates and screws.Possible, although improbable, sources of the debris could be the grinding of the screw head into the hole socket of the plate (over-zealous screw seating).Due to the lack of empirical evidence, or any evidence that can be objectively evaluated, this investigation cannot confirm the complaint as metallosis.No root cause of the concern can be determined at this time.
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