Device was used for treatment, not diagnosis.Additional narrative: patient id, dob & weight not provided by reporter.Event date: unknown when device cracked.The 510k#: device is not distributed in the united states, but is similar to device marketed in the usa.Not explanted.Unknown if device is/not expected to be returned for manufacturer review/investigation.(b)(6).Device history records was conducted.The report indicates that the: part 495.009vs / lot 9733145, please note, this dhr review is for sterilization procedure only: manufacturing location: (b)(4); supplier: (b)(4), manufacturing date: 19 november 2015, expiry date: 01 november 2025, no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Non-sterile 495.009v / 9717841 was manufactured in (b)(4), part number 495.009v, lot# 9717841, manufacturing location: (b)(4), manufacturing date: 04 november 2015, no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Part 495.009vs / lot 9718147, please note, this dhr review is for sterilization procedure only: manufacturing location: (b)(4), supplier: (b)(4), manufacturing date: 09 november 2015, expiry date: 01 november 2025, no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Non-sterile 495.009v / 9701603 was manufactured in (b)(4) part number 495.009v, lot# 9701603, manufacturing location: (b)(4), manufacturing date: 28 october 2015, no ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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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Device report from synthes on an event in (b)(6) as follows: it was reported that during surgery on (b)(6) 2016, the surgeon was unable to turn it in 90 degree and it made some strange noise.He tried to attach the cage to the implant holder again; however, it was not successful.When he checked in image, he found the cage seemed to have some crack.The surgeon decided to leave the cage in the patient's body and completed the surgery for a lumbar spinal canal stenosis (lscs).Lot number of the reported cage must be one of the followings; 9733145 or 9718147.The surgeon used two of the above cages and he was unable to specify which one had the issue.Lot number of the reported cage must be one of the followings; 9733145 or 9718147.The surgeon used two of the above cages and he was unable to specify which one had the issue.The surgery was prolonged about 5 minutes and there was no patient harm.This report is 1 of 1 for (b)(4).
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