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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI STERNAL LOCKING STRAIGHT PLATE/13 HOLES/WITHOUT PIN PLATE, FIXATION, BONE

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI STERNAL LOCKING STRAIGHT PLATE/13 HOLES/WITHOUT PIN PLATE, FIXATION, BONE Back to Search Results
Model Number 460.046
Device Problem Break (1069)
Patient Problems Inflammation (1932); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Additional product code: hwc. 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 or about (b)(6) 2018, patient underwent removal and replacement of synthes titanium external fixation system due to pain and implant breakage. Approximately 15 years ago, patient¿s right ribs were injured during strenuous horseplay around a pool. His ribs never properly healed from the injury, which resulted in a bone growth in his right ribs. The bone growth pinched the nerves in the area causing patient¿s muscle spasms and excruciating pain. On or about (b)(6) 2014, patient underwent resection of right 7 out of 8 ribs, with plating, using a synthes titanium sternal fixation system. In approximately (b)(6) 2017, while patient was resting at home, he felt a sudden painful snap in the area where the device was implanted. Following the incident, patient was in constant, intense pain and had experience grinding, and popping sensation in his torso and ribs in the area where the device was implanted. The implant has caused the patient to lose all stability in his chest and core and caused intense pain. The ongoing pain has disrupted the patient¿s activities of everyday living and prevented him from participating in activities he once enjoyed. On or about (b)(6) 2017, patient underwent imaging of his torso and ribs which revealed the implant to be split in half, approximately 1 inch from the end of the plate. On or about (b)(6) 2018, patient underwent surgery to have the synthes titanium external fixation system removed and replaced. After the removal, it was noted that the device had fractured approximately 1 inch from the end of the plate. On or about (b)(6) 2018, patient underwent imaging to ensure the successful replacement of the device. Patient still experienced ongoing inflammation in his rib joints, sternum, back shoulder, neck and right arm and, is still experiencing ongoing pain, and is no longer able to partake in the recreational activities he once enjoyed. This report is for one (1) sternal locking straight plate. This is report 1 of 1 for (b)(4).
 
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Brand NameTI STERNAL LOCKING STRAIGHT PLATE/13 HOLES/WITHOUT PIN
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 Key8197930
MDR Text Key131468326
Report Number2939274-2018-55586
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093772
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/30/2018
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? Yes
Device Operator
Device Model Number460.046
Device Catalogue Number460.046
Device Lot Number7288769
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2013
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
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