• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: CORTEX SCREW,FIXATION,BONE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: CORTEX SCREW,FIXATION,BONE Back to Search Results
Device Problems Break; Appropriate Term/Code Not Available
Event Type  Injury  
Manufacturer Narrative

This report is for an unk - screws: cortex/unknown lot. Part and lot numbers are unknown; udi number is unknown. Without a lot number the device history records review could not be completed. Product was not returned. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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.

 
Event Description

It was reported that on an unknown date, the patient underwent removal due to a non-union and two (2) unknown broken cortex screws in the distal portion of the lateral plate that was removed. Initially, the patient had implantation on an unknown date. Removal of plates and screws due to non-union and revision. Token screws and all hardware were successfully removed including a variable-angle locking compression plate (va-lcp) proximal tibia plate, locking compression plate (lcp) posteromedial proximal tibia plate, locking compression plate (lcp) plate, seven (7) unknown 3. 5 mm variable-angle (va) locking screws, three (3) unknown 3. 5mm locking screws, three (3) unknown 3. 5mm cortex screws, and four (4) unknown 2. 4 mm locking screws with no issue. After all, three (3) unknown plates were removed, a 4. 5 unknown lateral proximal tibia plate was placed to help hold stability. It is unknown if there was surgical delay. There was no patient consequence. Concomitant devices reported: variable-angle locking compression plate (va-lcp) proximal tibia plate (part# 02. 127. 231, lot# 9261708, quantity 1), locking compression plate (lcp) posteromedial proximal tibia plate (part# 02. 120. 702, lot# l345610, quantity 1), locking compression plate (lcp) plate (part# 247. 375, lot# unknown, quantity 1), unknown 3. 5 mm variable-angle (va) locking screws(part# unknown, lot# unknown, quantity 7), unknown locking screws (part# unknown, lot# unknown, quantity 3), unknown 3. 5mm cortex screws (part# unknown, lot# unknown, quantity 1), and unknown 2. 4 mm locking screws (part# unknown, lot# unknown, quantity 4). This is report 1 for 2 (b)(4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK - SCREWS: CORTEX
Type of DeviceSCREW,FIXATION,BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester , PA 19380
6103142063
MDR Report Key9147445
Report Number2939274-2019-61130
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/10/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

-
-