Catalog Number 498.119 |
Device Problems
Loose or Intermittent Connection (1371); Fitting Problem (2183)
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Patient Problems
Failure of Implant (1924); Non-union Bone Fracture (2369)
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Event Type
Injury
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Event Description
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Device report from synthes (b)(6) reports an event in (b)(6) as follows: it was reported that several click'x 3d-heads loosened from their pedicle screw counterparts postoperatively on level s1 left, s1 right, and l5 right.It is possible that the l5 left became loose as well, but it could not be seen during the explantation/revision procedure.The patient underwent an initial surgical procedure in 2012 on level l5, with an extension of the system onto s1 on (b)(6) 2014.The most recent procedure, a revision due to the loose 3d-heads, occurred on (b)(6) 2014.This report is 12 of 20 for (b)(4).
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Event Description
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An image reading of the x-rays was conducted by a medical director from this manufacturer and reported the following: ¿i have looked at the multiple images (ct scans and x-rays).While it is difficult to tell with complete certainty due to the limited views and quality of images, the images do suggest, in accordance with the complaint narrative, that there is loosening of the heads from the screws in the two caudal levels of the construct, particularly appreciated at s1 level.¿.
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Manufacturer Narrative
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(b)(6).Date of event: unknown.(b)(4).Original implant was on an unknown day in 2012.An extension of the implant occurred on (b)(6) 2014.A revision procedure took place on (b)(6) 2014, but it is unknown if the entire device was explanted.Device is expected to be returned for manufacturer review/investigation.(b)(6).Investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number was provided.Device 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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Additional narrative: 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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Additional narrative: a product development evaluation was completed: parts are used and show normal wear and tear.Visual inspection shows no unusual tear or damage to the implants.Potential cause of the failure could have been the choice of screw for a reduction; click on screw instead of preassembled.No product related fault could be found.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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The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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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Search Alerts/Recalls
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