MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE CAN SCR 6.0X50; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
|
Back to Search Results |
|
Catalog Number 199725650S |
Device Problem
Break (1069)
|
Patient Problems
Non-union Bone Fracture (2369); No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
Additional procode: kwp; kwq; mnh; mni; osh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
|
|
Event Description
|
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, the primary procedure with verse screws was performed to treat fracture.On (b)(6) 2020, a removal procedure was performed.The surgeon found that the screws had broken off.He decided to leave fragments in the patient¿s body for the following reasons: the fragments were located deep in the lesion.He assessed that fragments would not cause adverse effect to the patient.He commented the following: bone healing was not completed, so extra loading might have been put to the broken screws.Metal fatigue might have triggered the event.No further information is available.Concomitant device reported: unknown rods (part# unknown, lot# unknown, quantity unknown ); unknown setcrews (part# unknown, lot# unknown, quantity unknown).This report is for one (1) 5.5 exp verse can scr 6.0x50.This is report 1 of 2 for (b)(4).
|
|
Manufacturer Narrative
|
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.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.
|
|
Manufacturer Narrative
|
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.A review of the receiving inspection (ri) for 5.5 exp verse can scr 6.0x50 was conducted identifying that lot number 168270 was released in a single batch on (b)(6) 2016 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.A product investigation was completed: visual inspection of the complaint device showed that the screw was broken at the distal end of the quad lead threads.The broken screw piece was not returned.No x-rays or other photographs were provided.The dimensional inspection was not performed as the complaint relevant dimensions cannot be checked for dimensional accuracy due to post-manufacturing damage.The drawings reflecting the current and manufactured revisions were reviewed; no design issues or discrepancies were identified.The complaint was confirmed as the screw was broken at the distal end of the quad lead threads.While no definitive root cause could be determined based on the provided information, it is possible that the device was encountered unintended loading.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.
|
|
Manufacturer Narrative
|
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.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.
|
|
Manufacturer Narrative
|
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.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.
|
|
Search Alerts/Recalls
|
|
|