WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM LCP LATERAL DISTAL FIBULA PLATE 3H/LEFT/73MM; PLATE, FIXATION, BONE
|
Back to Search Results |
|
Model Number 02.112.137 |
Device Problem
Improper or Incorrect Procedure or Method (2017)
|
Patient Problem
No Code Available (3191)
|
Event Date 07/23/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
Patient information is unknown.Additional procode: hwc.Lot number is unknown.Device has not been explanted.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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.
|
|
Event Description
|
It was reported that on (b)(6) 2018, the sales consultant was checking a 3.5 lcp distal fibula tray to prepare for a case.He found that a left ankle plate and two (2) screws were missing.The hospital contact reported to him that on (b)(6) 2018, a patient was implanted with the missing left ankle plate on the right ankle.An x-ray was shown to the sales consultant to confirm that it was the device that was missing.Sales consultant has no copy of the x-ray.The procedure was completed.Patient's status is unknown.Concomitant devices: 2.7 mm locking screw self-tapping with t8 stardrive recess 10 mm (part: 202.210, lot: unknown, quantity: 2).This report is for a 2.7 mm/3.5 mm locking compression plate (lcp) lateral distal fibula plate 3-hole/left/73 mm.This is report 1 of 1 for (b)(4).
|
|
Search Alerts/Recalls
|
|
|