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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Pain (1994); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown plate and screw construct/unknown lot. Part and lot number are unknown; udi number is unknown. 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. (b)(4).
Event Description
This report is being filed after the review of the following journal article: magistroni e. , ciclamini d. , panero b. , verna v. , (2014)case report ultrasound-guided pulse-dose radiofrequency: treatment of neuropathic pain after brachial plexus lesion and arm revascularization , case reports in medicine volume article id 429618,pages 1-3 (italy). This study presents a case report of a male patient to describe the use of ultrasound-guided prf to reduce neuropathic pain (np) in a double-level nerve injury of the upper extremity. A case of (b)(6)-year-old man, who had sustained a complete left brachial plexus injury with cervical root avulsion and subclavian artery lesion in a motorcycle accident. An exposed distal humeral shaft fracture at the level of the elbow with median and ulnar nerve transection was also identified. The patient underwent humeral fracture stabilization (synthes locking compression plate; synthes, (b)(4), usa) and revascularization of the left arm. In july 2006, he underwent surgery of the brachial plexus lesion. Unfortunately, he did not show any sign of recovery of the motor function in the left upper limb, and in august 2008, a functional transfer of a gracilis free flap to brachial biceps and a wrist arthrodesis were performed. Over the last 6 years, the patient has undergone surgery 3 times and has followed a rehabilitation program. From the outset, the patient has been treated by searching for symmetry in orthostatic posture. The global postural rehabilitation technique has been used thus far in the course of rehabilitation. Since 2007, the patient has suffered from neuropathic pain (np) involving the ulnar side of the forearm, the proximal third of the forearm, and the thumb in both radial (dorsal) and median (volar) regions. From the outset until december 2010, np was successfully controlled with pregabalin, 600mg/day, and duloxetine, 75 mg/day. On rare occasions, severe pain was controlled with oxycodone and paracetamol, but with adverse side effects. Ultimately, satisfactory pain relief was obtained with morphine, 60 mg/day. In january 2011, the np gradually worsened and became localized in the ulnar side of the hand and the volar thumb. Because of the severe np, the patient was unable to wear a splint on his forearm and hand. He had continuous pain ranging from 3 to 9 on the visual analog scale (vas). The pain worsened when the patient was tired and after a busy and active day and was relieved by rest. Night rest was disturbed. As a result of pain worsening, we decided to perform prf treatment. Before applying the method, the patient underwent emg investigation (every 6 months since the beginning of the rehabilitation program). In february 2011 we carried out a diagnostic ulnar and median nerve block with ropivacaine 7. 5%. Both tests were positive, with complete pain relief lasting from 6 to 12 hours. Subsequently, a total of 5 ultrasound guided prf were performed on the ulnar nerve at the elbow level, with a mean period of pain relief after each treatment of about 4 months. The median nerve received a first prf treatment at wrist level, resulting in complete pain relief for 6 months. This report is for an unknown synthes locking compression plate. This is report 1 of 1 for (b)(4).
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Manufacturer (Section D)
eimattstrasse 3
oberdorf 4436
SZ 4436
Manufacturer Contact
kara ditty-bovard
1302 wrights lane east
west chester, PA 19380
MDR Report Key10472407
MDR Text Key205261450
Report Number8030965-2020-06492
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received08/17/2020
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: 08/31/2020 Patient Sequence Number: 1