MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problem Hypoesthesia (2352)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown screw/ rod construct accessory/ unknown lot.Part and lot numbers are unknown; udi 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.

Event Description

This report is being filed after the review of the following journal article: papadopoulos e., et al (2015) early outcomes and complications of posterior vertebral column resection, the spine journal volume 15, pages 983¿991, (usa).This retrospective study aims to report the outcomes obtained since 2002 with pvcr in properly selected patients with severe postinfectious or congenital kyphosis despite the lack of availability of resources at a scoliosis research society global outreach site (srs gop) in developing nations.Between 2002 and 2009, a total of 45 patients (20 males 25 females) with a mean age at the time of surgery of 14 years (range, 6¿47 years) who underwent pvcr for kyphosis from congenital deformity (nine) or secondary to tuberculosis of the spine (36) were included in the study.Several types of instrumentation were used including isola spinal system (depuy acromed, raynham, ma, usa) in 11 patients (in two the izola pediatric), miami-moss (depuy acromed) in nine patients, the expedia (depuy acromed) in three patients, and an anterior reconstruction titanium mesh cage (harms cage; depuy acromed) was used in 32 patients.Follow-up ranging from 2 to 79 months (average of 27 months).The following complications were reported as follows: patient case no.13 had abnormal motor strength, sensory, and bowel-bladder function postoperatively.Patient case no.22 had abnormal sensory and bowel-bladder function postoperatively.Patient case no.24 had abnormal sensory function postoperatively.Patient case no.33 sensory and motor strength function postoperatively.5 patients had chest tube placement postoperatively.2 patients were reintubated postoperatively.1 patient had spinal cord injury (sci).1 patient had transient nerve root injury with thoracolumbar osteotomies.1 patient had permanent nerve root injury with thoracolumbar osteotomies.4 patients had deep wound infection postoperatively and were reoperated.Three patients (one with hybrid instrumentation) developed a pseudoarthrosis and were reoperated.The total number of patients who underwent revision surgery for various reasons was ten out of 45.One patient developed a tuberculous psoas abscess that required surgical drainage.One patient with myelopathy that didn't improve after the pvcr, was reoperated for neuromuscular scoliosis 2 years after the index procedure.Myelopathy deteriorated in the last two (of the 11) patients who were wheelchair-bound at the final follow-up, despite the excellent decompression and correction.In six patients (four with hybrid instrumentation), the final correction was deemed suboptimal (less than 20 percent).Intraoperative monitoring changes occurred in 10 patients (22%) due to hypotension, extreme cord manipulation, or at the moment of osteotomy closure, these returned to normal after the appropriate maneuver in all but one patient who lost potentials at the time of the osteotomy and progressed to complete spinal cord injury when resuscitated.Three patients (one with hybrid instrumentation) developed a pseudoarthrosis and were reoperated; two of whom sustained a transient spinal cord injury at the time of the instrumentation failure.2 patients had a proximal failure.Two other patients with hybrid instrumentation, the proximal hooks dislodged; one was revised.This is report 4 of 10 for (b)(4).This report is for an unknown depuy spine isola spinal system, izola pediatric, miami-moss, or expedia screw/ rod construct accessory.This complaint is linked to (b)(4).

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• 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 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 9569481
• MDR Text Key: 189441554
• Report Number: 1526439-2020-00321
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• 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: 12/20/2019
• 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