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OBERDORF SYNTHES PRODUKTIONS GMBH TI COLLAR WITH GROOVES; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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| Catalog Number 498.011 |
| Device Problem
Break (1069)
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| Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Additional product codes: mni, mnh, kwp, kwq.(b)(4).The device was received, and the product evaluation is in progress.No conclusion can be drawn.Additionally, device history records review has been requested.Device was used for treatment, not diagnosis.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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Event Description
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Device report from synthes europe reports an event in (b)(6) as follows: it was reported that patient underwent an unknown spinal procedure at unknown levels on (b)(6) 2018 and was implanted with universal spinal system (uss) devices.During a follow up examination on unknown date, surgeon noted that the fracture clamp had released the transpedicular schanz screws.Patient was returned to surgery on (b)(6) 2018 where surgeon replaced both schanz screws.It is unknown if there was a surgical delay.Patient and procedure outcome is unknown.Upon visual inspection of the received device, it's clearly visible that the part is broken, but no issue reported from customer.Concomitant devices: fracture clamp (part 498.831, lot l327583 , quantity 1).Rod (part 04.620.150, lot 8778034 , quantity 1).Uss-sleeve toothed tan (part 498.011, lot 8492782 , quantity 1).Uss nut (part 498.003, lot 8029669, quantity 1).Uss nut (part 498.003, lot 8128799 , quantity 1).Schanz screws (part unknown, lot unknown, quantity 2).This report is for one (1) ti collar with groove.This is report 3 of 3 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Part 498.011, lot 2757208: manufacturing site: bettlach.Release to warehouse date: july 09, 2011.The device history record shows this lot of devices was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all criteria at the time of release with no issues documented during the manufacturing process.The raw material certificate was reviewed and the used material was according to specification.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.H3, h6: a product investigation was completed: upon visual inspection of the complaint device it can be seen that the received part is broken, this thus confirming the complaint description.A device history record (dhr) review was performed for the affected lot, the devices were delivered to the warehouse, no abnormalities or deviations were detected, which could lead to the complaint failure.The article was manufactured in july 2011.No non-conformance reports (ncrs) were marked in the dhr during production.Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy.The raw material certificate was reviewed and the used material was according to specification.Unfortunately we are not able to determine the exact reason for this occurrence, but it is likely that during the operation an application error may have taken place.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.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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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Updated event description provided for reporting.Explant date provided for reporting.Device was used for treatment, not diagnosis.
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Event Description
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(b)(6) 2019 updated event description: device report from synthes europe reports an event in austria as follows: it was reported on october 30, 2018, that a patient underwent a spinal procedure with an implantation of the (uss) universal spinal system on april 11, 2018.During a follow-up examination, the surgeon noticed that the fracture clamp released the transpedicular schanz screws.That opted a revision surgery on (b)(6) 2018, where the surgeon replaced both screws.It is unknown if there was a surgical delay.Patient and procedure outcome is unknown.Concomitant devices reported: unknown - schanz screws (part# unknown, lot# unknown, quantity#1), uss-sleeve toothed tan (part# 498.011, lot# unknown, quantity#1), uss nut f/uss-var-axis-scr uss-pedicscr+ (part# 498.003, lot# 8029669, quantity#1), uss nut f/uss-var-axis-scr uss-pedicscr+ (part# 498.003, lot# 8128799, quantity#1), fract-clamp f/r ø6 low profile tan light; (part# 498.831, lot# unknown, quantity#1), rod ø6 soft curv l50 ti: (part# 04.620.150, lot# 8778034, quantity#1).
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