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Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problems
Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 01/06/2021 |
Event Type
Injury
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Manufacturer Narrative
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Procode: trinica(r) anterior cervical plate system, trinica(r) select anterior cervical plate system.Reference reports 3012447612-2021-00020 thru 3012447612-2021-00027.Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Event Description
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It was reported that a screw fractured and backed out post-op, which caused the construct to be unstable and fusion was not achieved.Additionally, the cage was found to be cracked.A 2-level plate, 6 screws, and cage were removed during a revision surgery.This is report four of eight for this event.
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Event Description
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It was reported that a screw fractured and backed out post-op, which caused the construct to be unstable and fusion was not achieved.Additionally, the cage was found to be cracked.A 2-level plate, 6 screws, and cage were removed during a revision surgery.This is report four of eight for this event.
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Manufacturer Narrative
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Added information to d3: email address, h6: component codes, health effect-impact code, type of investigation, investigation findings, investigation conclusions this follow-up report is being submitted to relay additional information and initially corrected information.Summary: the complaint is confirmed for one (1) of six (6) returned 10x4.2mm sd var scr (pn 07.00812.0xx) for the failure of screw fractured and migrated post-operation.The complaint is confirmed for five (5) of six (6) returned 10x4.2mm sd var scr (pn 07.00812.0xx) for the failure of construct did not provide fusion.T.Medical records were provided in form of x-rays.The provided x-rays confirms that an implant was migrated.Potential cause: despite the products were returned for evaluation, root cause can't be established.Patient conditions and events prior to the surgery are not known.Insufficient information was provided.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
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Search Alerts/Recalls
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