The event was reported to the medwatch program (report # mw5078247) on (b)(4) 2018 by the and officially received by the fda on 7/3/2018.The reported date of the surgery on the medwatch form is (b)(6) 2017.Renovis reviewed sales records for all alif cages used in surgeries on the reported date.There were two titanium alif surgeries completed on (b)(6) 2017: the first was completed by a surgeon in (b)(6).The surgeon reviewed the patient record, including an mri, and stated that the cage in his patient has not fractured.The second was completed by a surgeon in (b)(6).Marketing reached out to the surgeon who also reviewed the patient record, including an mri, and stated that the cage in his patient has not fractured.Renovis is unable to identify the cage used or location of surgery as both surgeons that implanted titanium cages on the reported surgery date have stated that the cages in their patients have not fractured.
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Renovis received medwatch report mw5078247 through the u.S.Mail on 7/16/2018.Per the medwatch report, a voluntary event report was received for a "tesera 3-d printed alif cage." per the report, the "renovis alif cage could not withstand normal, axial load and in turn, the lateral aspect of the cage has fractured and is collapsed." this event is classified as "serious injury" per the medwatch report.
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