This report is for an unknown metaphyseal locking compression plate (lcp)/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.(b)(4).
|
This report is being filed after the review of the following journal article: yang, q.Et al (2012), surgical treatment of adult extra-articular distal humeral diaphyseal fractures using an oblique metaphyseal locking compression plate via a posterior approach, medical principles and practice, vol.21 (1), pages 40-45 (china).The aim of this retrospective study is to determine the effects of open reduction and internal fixation of displaced fractures of the adult extra-articular distal humeral diaphysis using the ao (association for the study of internal fixation) metaphyseal locking compression plates (mlcp).Between july 2006 to august 2009, a total of 19 adult patients (15 men and 4 women) with extra-articular distal humeral diaphysis fractures were surgically treated using the ao mlcp via a posterior approach.The mean age of 36.7 years (range 20¿75).Then mean follow-up time is 16.6 months (range from 12 to 20).The following complications were reported as follows: a (b)(6) year-old male patient, who had fracture due to a motor-vehicle accident (mva), had iatrogenic radial nerve palsy which recovered completely within 2.5 months after the operation.A (b)(6) year-old male patient, who had fracture due to fall, complained of pressure on the overlying skin.Implants were removed, then further rehabilitation was subsequently performed, and patients showed good functional outcome.A (b)(6) year-old male patient, who had fracture due to mva, also complained of pressure on the overlying skin.Implants were removed, then further rehabilitation was subsequently performed, and patients showed good functional outcome.At final follow-up, varus deformity of 3° were observed.A (b)(6) year-old male patient, who had fracture due to fall, were found to have varus deformity of 3° at final follow-up.A (b)(6) year-old male patient, who had fracture due to mva, were found to have a valgus deformity of 2° at final follow-up.The mean active forward flexion of the shoulder was 165.3 8 4.6° (range 160¿170).The university of california at los angeles scoring system rated 12 (63.2%) patients as showing excellent results and 7 (36.8%) as showing good recovery.The mean active forward flexion of the elbow was 135.0 8 2.4° (130¿140).The mayo elbow performance scoring system rated 10 (52.6%) cases as excellent results, 6 (31.6%) as good and 3 (15.8%) as fair.This report is for a (b)(6) year-old male patient who had iatrogenic radial nerve palsy.This report is for an unknown metaphyseal locking compression plate (lcp).This is report 1 of 6 for (b)(4).
|