MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN LAMINA/PEDICLE/PROCESS HOOKS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown lamina / pedicle / process hooks / unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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: pati b., et al (2004) thoracolumbar spine injuries-comparison of 4 different posterior spinal instrumentation systems, indian journal of orthopaedics volume 38 (2), pages 96-99, (india).This study aims to compare the efficacy of the classic harrington, hartshill and steffe system and newer pedicle screw rod systems in attainment and maintenance of reduction (i.E., vertebral body height and percentage reduction of horizontal translation) of thoracolumbar spine fractures and also to assess the complication rates and safety of the above systems in the treatment of thoracolumbar spine fractures.A total of 147 patients (98 males and 49 females) average age was 24 years (range - 16 years to 53 years) of thoracolumbar spine fractures with partial or complete neurological deficit were included in this study.These patients were operated using posterior approach.Harrington rod fixation was performed in 55, hartshill in 19 patients, steffee (pedicle screw and plate) in 51 patients and newer pedicle screw rod systems [moss miami system and universal spine stabilisation system - ao] in 22 patients.Standard midline posterior approach was used in all patients.The patients were reviewed at 1 month, 3 months, 6 months, 1 year and 2 years from the date of surgery and the following radiological and clinical parameters were noted in the immediate postoperative period and in the successive visit.The following complications were reported as follows: 1 case of loss of reduction of vertebral height.1 case of nerve root injury.1 case of csf leakage.Cases of pain on mobilization.1 pedicle/ lamina fracture.Almost all the patients in frankel's grade a did not show improvement: 9 patients with frankel a (complete injuries), treated with pedicle screw.Neurological status of 9 patients treated with pedicle screw rod were unchanged.1 case of screw cutout.This report is for an unknown depuy spine pedicle screw rod systems moss miami.It captures adverse event of 1 pedicle/ lamina fracture.This is report 3 of 3 for complaint (b)(4).

• Brand Name: UNKNOWN LAMINA/PEDICLE/PROCESS HOOKS
• 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 (Section G): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9566078
• MDR Text Key: 189437986
• Report Number: 1526439-2020-00300
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2019
• 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