It was reported that, after a surgery was performed in which two multifix s ultra 5.5 mm had been implanted six months ago, it was found during the sonographic follow-up examination of the patient that the anchor has loosened.The patient complains of pain and restricted movement, so a sonographic examination was carried out and the loosening of the anchor, impingement at 90° was found.A revision surgery is planned for (b)(6) 2020.
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The device used in treatment, was not returned for evaluation.Per picture of the device, there was a relationship found between the reported incident and the returned device.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A review of risk management files found that the reported failure was documented appropriately.A review of the instructions for use found: pathologic bone conditions such as cystic changes or severe osteopenia, which would impair secure fixation of the implant.Pathological changes in the affected soft tissues, which would prevent secure fixation.Inadequate bone stock or comminuted bone surface(s), which would compromise secure fixation of the implant.- physical conditions that would eliminate or tend to eliminate adequate implant support or retard healing, i.E., blood supply limitation, previous infections, etc.- conditions such as senility, mental illness or alcoholism, which may impact the patient¿s ability or willingness to restrict activities or comply with physician instructions during the healing period.-do not implant the anchor in poor quality bone or where bone quantity is limited.Incomplete insertion or poor bone quality may result in implant pullout.Clinical/medical evaluation was completed and concluded that the images provided are reported to indicate anchor loosening.With the images alone this is plausible but cannot be confirmed.Based on the information provided the root cause of the reported issue could not be determined.The revision was reported to be aug 6, 2020 but no new information has been provided to support the complaint.The patient impact beyond the reported of pain and restricted movement cannot determined.No further clinical/medical assessment is warranted at this time.Visual evaluation of x-ray image suggests anchor loosening.The complaint is confirmed.Factors that could have contributed to the reported event include: (1) bone quality (2) bone hole size.No containment or corrective actions are recommended at this time.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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