Catalog Number 39-SK-6545 |
Device Problem
Fracture (1260)
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Patient Problem
Implant Pain (4561)
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Event Date 02/26/2024 |
Event Type
Injury
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Manufacturer Narrative
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H3 other - evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.
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Event Description
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It was reported that a l4/l5/s2a1 procedure was performed in australia on (b)(6) 2022, utilizing the reform ti modular cannulated pedicle screw system.Subsequently, the patient presented with pain and radiographs showed compression of the construct and a broken screw in l4, right side.Revision procedure was performed on (b)(6) 2024, during which the broken 45mm reform ti modular cannulated screw (39-sk-6545) was confirmed and it was noted that the left side l4 screw showed significant loosening.Both the proximal and distal ends of the broken screw were removed and replaced along with the loose screw on the right side.In addition, screws were also placed in the two levels above with the remainder of the original construct left in place.Image provided shows cage migration in the disc space just under the broken screw.
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Manufacturer Narrative
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H3 device evaluation - both the proximal and distal segments of the broken screw were returned for evaluation.The distal segment fracture site is marred.The marring is likely due to tools used to help extract that segment from the pedicle.Due to this visual assessment of those surfaces are not practical other than noting that the fracture is along the screw's minor diameter.The proximal segment was reviewed with the aid of a 5x loop.It is believed that the screw fractured via low cycle fatigue.The cause for this fracture is believed to be related to the condition of the construct.Instability appears to exist with the complaint noting that the cage had migrated and as evidenced in the x-ray that was provided.The x-ray shows signs of cage looseness (darkness around the cage).After more than 1 year and 9 months this revision took place.Review of device history records found 243 pieces of this lot released for distribution on (b)(6) 2020 with no deviation or anomalies.Two-year complaint history review did not reveal a trend for reports of this nature for this product family.No corrective actions are recommended at this time.
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Event Description
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It was reported that a l4/l5/s2a1 procedure was performed in australia on (b)(6) 2022, utilizing the reform ti modular cannulated pedicle screw system.Subsequently, the patient presented with pain and radiographs showed compression of the construct and a broken screw in l4, right side.Revision procedure was performed on (b)(6) 2024, during which the broken 45mm reform ti modular cannulated screw (b)(6) was confirmed and it was noted that the left side l4 screw showed significant loosening.Both the proximal and distal ends of the broken screw were removed and replaced along with the loose screw on the right side.In addition, screws were also placed in the two levels above with the remainder of the original construct left in place.Image provided shows cage migration in the disc space just under the broken screw.
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Search Alerts/Recalls
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