• 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 - PLATES: CLAVICLE 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 UNK - PLATES: CLAVICLE PLATE, FIXATION, BONE Back to Search Results
Catalog Number UNK - PLATES: CLAVICLE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Non-union Bone Fracture (2369)
Event Type  Injury  
Event Description
This is report 1 of 3 for (b)(4). It was reported by the patient that on (b)(6) 2021, she noticed a softball sized orange spot on the worn finish of the very old cast-iron bathtub where the shoulder touched while taking a bath. According to the patient, that spot continued to be there and had not faded nor expanded. It was reported that the orange chromehidrosys from the shoulder was the result of metallosis from the plate. The patient also experienced significant pain and inflammation in the right upper chest and arm during the time the plate was attached to the clavicle that was relieved within two days after its removal. This was an allergic reaction to the plate. The patient also reported that she feels she has a metal sensitivity. She experienced constant pain and sensitivity around plate until it was removed. Patient also stated that two screws were sitting proud and caused pain when she breathed. Patient also experienced a delayed union, which required a bone stimulator. Patient declined to provided any additional information. This report is for one (1) unk plates: clavicle device. This complaint involves one (1) device.
 
Manufacturer Narrative
Additional narrative: 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. This report is for an unknown device/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. The lot number was unknown. Therefore, the expiration date and device manufacture date were unknown. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNK - PLATES: CLAVICLE
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key14251115
MDR Text Key290394508
Report Number2939274-2022-01545
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK - PLATES: CLAVICLE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/03/2022
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? No

Patient Treatment Data
Date Received: 04/29/2022 Patient Sequence Number: 1
-
-