• 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 3.5MM LCP PLATE 12 HOLES 163MM PLATE, 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 3.5MM LCP PLATE 12 HOLES 163MM PLATE, FIXATION, BONE Back to Search Results
Model Number 223.621
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
Additional product codes: hwc, ktt. 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.
 
Event Description
It was reported that on (b)(6) 2018, the patient underwent a hardware removal of one (1) unknown 3. 5 mm locking screw that was broken and one (1) unknown 5mm cannulated locking screw that was cold welded to 4. 5mm locking compression plate (lcp) proximal tibia plate 12 holes/226mm left due to infection. The plate had to be cut away to remove the screw. All implants including three (3) unknown 5. 0 mm cannulated screws, six (6) unknown locking screws, four (4) unknown cortex screws, (1) unknown locking screw, and one (1) unknown cannulated screw were removed successfully. There was difficulty removing the fragments that were generated from the broken device and trephine was used to remove the screw head. Original implantation was on (b)(6) 2015, for an open reduction and internal fixation (orif) of the proximal tibia. The procedure was completed successfully. There was no surgical delay. The patient outcome was stable. This complaint captures the post-operative infection and broken screws. The intra-operative event involving the plate being cut away is captured under related complaint (b)(4). This report is for a 12-hole locking compression plate. This is report 2 of 7 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name3.5MM LCP PLATE 12 HOLES 163MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
ELMIRA
35 airport road
horseheads NY 14845
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
6103142063
MDR Report Key8196923
MDR Text Key131417728
Report Number2939274-2018-55574
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082807
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number223.621
Device Catalogue Number223.621
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 Received12/03/2018
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

Patient Treatment Data
Date Received: 12/26/2018 Patient Sequence Number: 1
-
-