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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN RODS ROD, FIXATION, INTRAMEDULLARY

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MEDOS INTERNATIONAL SàRL CH UNKNOWN RODS ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem No Apparent Adverse Event (3189)
Patient Problems Neurological Deficit/Dysfunction (1982); Paralysis (1997)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown rod/ unknown lot. Part and lot numbers are unknown; udi number is unknown. Without a lot number the device history records review could not be completed. Product was not returned. 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) 2015, the patient presented with the complaints of shoulder pain which revealed scoliosis obtained on radiological studies. However, they failed to diagnose scoliosis or have the patient scoliosis evaluation. On (b)(6) 2018, the patient came with the complaints of upper back pain primarily in the left-mid-thoracic spine radiating to the left and right buttocks. The pain was intermittent, moderate ache with no history of back pain before. On (b)(6) 2018, the patient explained that he had low back pain and occasional thigh pain. The patient denied of radiating pain, numbness or tingling in her extremities. The patient was scheduled then with posterior instrumented fusion t2 to l4 vertebral bodies. The need for the surgery was urgent because it was not detected earlier. On (b)(6) 2018, the surgeon recommended and agreed to have urgent surgery to the patient with more conservative treatment. On (b)(6) 2018, they began the surgery (posterior instrumented fusion t2 to l4. But when the patient awoke from the surgery, the patient was completely paralyzed from her chest down with the motor-sensory loss from t4 to her toes. And now suffers from dysreflexia. No further information available. This report is for one (1) unknown rod. This is report 1 of 10 for (b)(4). This (b)(4) capture the 10 out of 64 devices reported/ received, (b)(4) capture the 10 out of 64 devices reported/ received, (b)(4) capture the 10 out of 64 devices reported/ received, (b)(4) capture the other 10 out of 64 devices reported/ received, (b)(4) capture the 10 out of 64 devices reported/ received, (b)(4) capture the 10 out of 64 devices reported/ received and (b)(4) capture the 4 out of 64 devices reported/ received.
 
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Brand NameUNKNOWN RODS
Type of DeviceROD, FIXATION, INTRAMEDULLARY
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS INT SPINE
chemin blanc 38
le locle
SZ
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key10043370
MDR Text Key194125900
Report Number1526439-2020-00953
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2020
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/03/2020
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: 05/11/2020 Patient Sequence Number: 1
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