Model Number N/ |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/07/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: qty: 2 : titanium pectus elongated stab, cat# 01-3802, lot#ni.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 - 00205, 0001032347 - 2021 - 00206.
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Event Description
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It was reported that a pectus bar and two stabilizers were explanted approximately two months postimplantation due to dislocation of the bar from the stabilizer.The surgeon plans on reinsertion in the near future.Attempts have been made and additional information on the reported event is unavailable at this time.
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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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No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records for the pectus bar identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: two views of the chest demonstrate postoperative changes from reconstruction of a pectus excavatum procedure with dislodgment of the pectus bar from the stabilizer on the left side of the patient.The overall fit of the implant is appropriate.No correlating factors can be identified for the dislodgement of the pectus bar from the stabilizer on the left side of the patient.The patient op notes were reviewed: the patient was diagnosed with having severe pectus excavatum.She had worsening shortness of breath and chest discomfort over a period of several months prior to the procedure.She had no significant symptoms since childhood and did not consider surgical repair until now.More recently, she has been unable to do her active exercises because of shortness of breath and chest discomfort.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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