MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: EXPEDIUM; 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

There are multiple patients all information is provided in the article.This report is for an unknown mono/polyaxial screw/unknown lot.Part and lot number 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: quan, g.M., and wilde, p.(2013), fractured neck of femur below long spinopelvic fixation for charcot spine: a case report, journal of medical case reports, vol.7, pages 1-5 (australia).This study presents a case report of a (b)(6) year-old caucasian man who presented with a 6-month history of lethargy, increasing lower torso and lower limb spasms associated with severe sweating, hypertension and recurrent headaches.Plain x-rays showed severe bony reabsorption and destruction distal to the previous fusion coupled with new bone formation around the destroyed l4 vertebra.A computed tomography (ct) scan showed extensive endplate and osseous destruction of his l3 and l4 vertebral bodies, with gas vacuum phenomenon at this level.A magnetic resonance imaging scan confirmed the bony and soft tissue destruction at l3 and l4, as well as showing abnormal paravertebral soft tissue and a complex paraspinal 7cm diameter mass within his psoas muscle with associated multifocal and multilocular fluid collections, areas of dystrophic ossification and nonspecific soft tissue inflammatory changes.The first surgery involved a posterior approach and extension of the previous fusion from l3 to s1 with pedicle screws and rods (expedium® spine system, depuy spine, raynham, ma, usa).The second surgery was performed after 1 week and involved a direct lateral trans-psoas retroperitoneal approach to l4, where extensive destruction with bony debris was observed.L4 corpectomy and anterior reconstruction using an expandable titanium cage stabilized with vertebral body staples and screws in l3 and l5 held with a 6.25mm diameter rod (legacy¿ spinal system, medtronic sofamor danek, memphis, tn, usa) was performed.At his third surgery, it was revealed that there was severe loosening of the l5 and s1 screws bilaterally and involving revision and extension of the posterior instrumentation to his ilium with screws and cobalt-chrome rods (expedium).Radiographs taken at 6 weeks postoperatively showed a stress response of the bone on the contralateral (left) side, with periosteal bone formation in the subtrochanteric region.This report is for an unknown depuy spine expedium.This report is for one (1) unknown mono/polyaxial screw.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: 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 for one (1) unk - mono/polyaxial screws: expedium.

Event Description

This report is for unk - constructs: expedium.

• Brand Name: UNK - CONSTRUCTS: EXPEDIUM
• 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 INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle ; SZ ; 6103142063
• MDR Report Key: 12435969
• MDR Text Key: 270218108
• Report Number: 1526439-2021-01865
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• 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: 12/08/2021
• 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
• Patient Age: 42 YR
• Patient Sex: Male