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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. LOCK DISTAL FIBULA PLT,SS LFT,4H PLATE, FIXATION, BONE

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ARTHREX, INC. LOCK DISTAL FIBULA PLT,SS LFT,4H PLATE, FIXATION, BONE Back to Search Results
Model Number LOCK DISTAL FIBULA PLT,SS LFT,4H
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Fatigue (1849); Headache (1880); Tinnitus (2103); Dizziness (2194)
Event Date 11/22/2019
Event Type  Injury  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The root cause of the event could not be determined from the information available and without device evaluation.
 
Event Description
It was reported by the patient that she had an original ankle procedure (b)(6) 2017. During the surgery six arthrex products were implanted. The patient developed allergic like reaction symptoms and recently had to undergo a second surgery on (b)(6) 2019 to explant the arthrex devices. Patient did not have an further details at the time of report but will provide soon. Additional information 1/8/2020: original procedure was on (b)(6) 2017 and was a left ankle orif. Following surgery the patient was in the hospital for three nights. She started having ringing in her ears and dizziness 3 months after surgery. This was followed by tiredness, migraines, and tmj on her right side. She also developed noticeably drier, flaky skin and more anxiety after about 6 months. She developed food intolerance to dairy and developed a thyroid nodule as well. Patient had a second surgery on (b)(6) 2019 to explant all of the original implant devices. The second surgery was performed by a different surgeon at a different facility. The following devices were reported to have been implanted on (b)(6) 2017 and explanted on (b)(6) 2019 (specific arthrex part numbers were not provided): ar-8926ss, knotless tightrope syndesmosis repair implant, lot 17016. Ar-1688-cp, implant system, internal brace ligament augmentation repair with collagen coated fibertape, lot 10127689. Ar-8943bl-04, locking dital fibula plate, ss, left, 4 hole, lot unknown. Ar-8827l-10, qty 2, low profile locking screw, ss, 2. 7 x 10mm. Ar-8827l-12. Low profile locking screw, ss, 2. 7 x 12mm. Ar-8835-14, qty 3, low profile nonlocking cortical screw, ss, 3. 5 x 14 mm. Patient reports she did not keep the implants because she did not want them. Patient also stated the tissue looked ok but that it does not rule out metallosis.
 
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Brand NameLOCK DISTAL FIBULA PLT,SS LFT,4H
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key9631382
MDR Text Key186281500
Report Number1220246-2020-01607
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141478
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 01/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberLOCK DISTAL FIBULA PLT,SS LFT,4H
Device Catalogue NumberAR-8943BL-04
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/27/2020 Patient Sequence Number: 1
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