This report is for an unknown 2.4-mm variable angle lcp (va-lcp) two-column volar distal radius plate construct/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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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This report is being filed after the review of the following journal article: lee j-k, et al (2020), volar locking plate removal after distal radius fracture: a 10-year retrospective study, archives of orthopaedic and trauma surgery, pages 1-9, (south korea) this study aimed to compare characteristics of patients who underwent volar locking plate fixation with and without subsequent implant removal.Second, the rate of implant removal according to the implant position and type was investigated.Between january 1, 2008, and december 31, 2017, 806 patients with a total of 814 distal radius fractures were included in the study.A total of 252 patients had implant removal which comprised of 94 males and 158 females with a mean age of 50.8+/- 14.0 years.A volar locking plate fixation for distal radius fractures was performed using a modified henry approach to the fractured distal radius in-between the flexor carpi radialis and the tendons of the brachioradialis.Regarding the inserted volar locking plate, only 1 manufacturer (depuy synthes) was used, but 5 different types of plates were used depending on the fracture patterns.The plates used were the unknown synthes 3.5-mm locking compression plate (lcp) t-plate, unknown synthes 2.4-mm variable angle lcp (va-lcp) two-column volar distal radius plate, unknown synthes 2.4-mm lcp distal radius system /extra-articular, unknown synthes 2.4-mm lcp distal radius system /juxta-articular, and unknown synthes 2.4-mm va-lcp volar rim distal radius plate.Complications were reported as follows: 186 patients underwent implant removal without clinical symptoms after bony union.13 patients underwent implant removal due to carpal tunnel syndrome.11 patients underwent carpal tunnel release together with implant removal.13 patients underwent implant removal in combination with removal of other implants.12 patients underwent removal due to unclear source of discomfort or pain.3 of these patients complained of persistent pain even after implant removal.8 patients underwent removal due to foreign body sensation.6 patients had newly developed postoperative pain with subsidence during outpatient follow-up after implant removal.5 patients complained of numbness or tingling sensations along the median nerve or around the operative scar after implant removal.This report is for the unknown synthes 2.4-mm variable angle lcp (va-lcp) two-column volar distal radius plate construct.A copy of the literature article is being submitted with this medwatch.This is report 4 of 5 for (b)(4).
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