WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES: MATRIX ORBITAL; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
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Device Problems
Defective Device (2588); No Apparent Adverse Event (3189)
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Patient Problems
Nerve Damage (1979); Blurred Vision (2137); Non-union Bone Fracture (2369); Numbness (2415); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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Event Description
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It was reported that on (b)(6) 2021, patient had a psi plate placed on right cheek extending to the orbital socket.The plate was not the correct size and surgical procedure was extended to make adjustments to implant device.After the surgery, the patient is experiencing numbness, nerve damage, vision problems and face asymmetry.There are no plans to do a revision surgery.This report is for an unknown psi implant.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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This report is for an unknown psi implant/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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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Event Description
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The initial complaint was reviewed and found not reportable.Upon further review it was identified that the materialise is the legal manufacturer for the complaint device and materialise has also reported this complaint to fda.
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Event Description
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On (b)(6), 2021, patient underwent revision due to non-united fracture through inferolateral left maxilla sinus wall.Operative reports structural injury due to compression of the infraorbital foramen.This is report 1 of 17 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: a2, a3, a4, b5, b6, b7.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.H11: corrected data: b5, e1, b1, h1, h6: it was determined the device was a synthes device and not a materialise device.
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Search Alerts/Recalls
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