MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN RODS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problem Break (1069)

Patient Problems Cyst(s) (1800); Spinal Column Injury (2081)

Event Date 05/03/2010

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unk - rods/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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date that the patient underwent a surgical procedure for t4-t6 decompression and posterior stabilization on (b)(6) 2010.On (b)(6) 2010 the patient was transferred to (b)(6) hospital due to complete paraplegia at t2 and spasms in flexion in the lower limbs of moderate grade.The patient was discharged on (b)(6) 2010.The patient went for implant removal surgery on an unknown day of (b)(6) 2016 with the symptom of syringomyelia, rupture of the connection between the cervical side and the dorsal one, rupture of the stabilizer bars.It was unknown if there was surgical delay.The patient outcome was unknown.This complaint involves one (3) device.This is 1 of 3 for report (b)(4).

• Brand Name: UNKNOWN RODS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 9850375
• MDR Text Key: 193129950
• Report Number: 1526439-2020-00731
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention