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Model Number N/A |
Device Problem
Migration (4003)
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Patient Problems
Failure of Implant (1924); Inflammation (1932); Irritation (1941); Pain (1994); Pneumothorax (2012); Discomfort (2330); Malunion of Bone (4529)
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Event Date 10/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00067.Two screw identities were provided for the implantation surgery, but the identity of the loose screw was not provided.The screw may be either of the following entries: ribfix blu system screw, self-drilling, cancellous x-drive locking 2.4 x 8mm, part# 76-2408, lot# ni, udi (b)(4).Ribfix blu system screw, emergency, cancellous x-drive locking, part# 76-2708, lot# ni, udi (b)(4).Concomitant medical products: ribfix system 8 hole straight plate, part# 76-2601, lot# ni, ribfix blu system 12 hole pre-bent plate, part# 76-2602, lot# ni, ribfix blu system screw, self-drilling, cancellous x-drive locking 2.4 x 8mm, part# 76-2408, lot# ni, ribfix blu system screw, emergency, cancellous x-drive locking, part# 76-2708, lot# ni.
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Event Description
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It was reported the patient underwent a revision to remove rib fixation devices on the left 10th rib due to plate fracture and loose screw three (3) years following implantation.Prior to the revision, the patient reported she was exercising and felt a pop in her chest with a sharp pain.Imaging revealed a fractured plate and loose screw.The patient underwent removal of all hardware and partial rib resection due to surrounding irritation.A partial pneumothorax was discovered and corrected during the procedure.The patient was discharged the next day without complication.It was reported that no further information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Photographs were received that capture the fractured plate.Two (2) plates were originally implanted and the plate identities were as follows: ref (b)(4) lot unk straight plate 8 hole, and ref unk lot unk 12 hole plate.The photos show a fractured plate with at least nine (9) holes and ref 762601 lot unk straight plate 8 hole is not applicable.D10 ¿ medical products: unknown 12 hole rib plate, part# ni, lot# ni.This report is being submitted to update additional information in section d10, h2, and h10.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.Medical records were provided and reviewed by a health care professional.It was reported that a patient underwent an orif with unknown plate and screws of the 10th posterolateral rib due to a soccer injury on (b)(6) 2016.The plate and screws were later revised due to an unknown implant failure.Subsequently, the patient reported she was exercising and felt a pop in her chest with a sharp pain.Radiology scans revealed a fractured plate and loose screw.On (b(6) 2019, the patient underwent removal of all hardware and partial rib resection due to surrounding irritation.A partial pneumothorax was discovered and corrected during the procedure.The patient was discharged the next day without complication.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in section h2, h3, h6 and h10.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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Two screw identities were provided for the implantation surgery, but the identity of the loose screw was not provided.The screw may be either of the following entries: ribfix blu system screw, self-drilling, cancellous x-drive locking 2.4 x 8mm, part# 76-2408, lot# 722290.Ribfix blu system screw, emergency, cancellous x-drive locking, part# 76-2708, lot# j098930.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information is available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Seven (7) screws were returned.Inspection of the screws found no damages.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.Analysis performed by optical microscope and sem (scanning electron microscope) on the ribfix plate sample showed that the fractured surfaces were excessively smeared as well as obscured with biological debris.There was no conclusive evidence identified on the fracture surfaces of the ribfix plate sample to determine the mode of failure.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information is available at the time of this report.
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Search Alerts/Recalls
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