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

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.

• Brand Name: UNKNOWN RODS
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL 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 Key: 10043370
• MDR Text Key: 194125900
• Report Number: 1526439-2020-00953
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 05/11/2020
• 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 Received: 06/03/2020
• 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