MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE UNITIZED SET SCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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Model Number 199721001S |
Device Problem
Migration (4003)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Type
Injury
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Manufacturer Narrative
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Additional procode: kwp; kwq; mnh; mni; osh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, a primary fusion procedure at l1~sai was performed.Verse system was applied to l1/s, and expedium sai was used at sai.On (b)(6) 2021, they found that the rod which was deployed at l1 right had come off the screw¿s head.Additionally, the setscrew had been placed in the screwhead.During the revision procedure, the fusion was extended up to th10 without any issue.No further information is available.This report is for one (1) 5.5 exp verse unitized set scr.This is report 2 of 3 for (b)(4).
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Manufacturer Narrative
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Product complaint # (b)(4).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.H10 additional narrative: d4: update.D10: updated concomitant device reported.H3, h6: the subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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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Product complaint # (b)(4).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.H3, h6: investigation summary: the product was returned to the us cq for evaluation.Us cq conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the set screw implant distal end surface was slightly deformed.The dimensional inspection of the received device revealed that the device was conforming to the specifications.The cause for the deformation could not be identified.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of depuy spine¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as it was observed that the set screw implant was slightly deformed at the distal end.While no definitive root cause could be determined, it is possible the observed deformation issue would contribute to the alleged rod implant migration issue.There was no indication that a design or manufacturing issue contributed to the complaint.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 dimensional inspection: the dimensional inspection was performed.Document/specification review: all relevant drawing are reflecting the current and manufactured revision was reviewed.Device history lot: the dhr of product code: 199721001s, lot : xd1133 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 04.17.2020 qty: (b)(4).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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