MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: EXPEDIUM VERSE; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: expedium verse/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.Reporter is a j&j employee.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 a clinical evaluation report (cer) from a related research activity database (ddra) for 56 patients undergoing spinal surgery with the expedium verse system.Twenty-two (12 females and 10 males )of the 56 patients were pediatric patients.More of the pediatric patients were female with a mean age of 14.9-1.8 years.The mean follow-up for this group was 21.7-10.7 months.Thirty-four (24 females and 10 males ) of the 56 patients were adult patients.More of the adult patients were females with a mean age of 45.9-18.4 years.The mean follow-up for this group was 30.4-17.6.Pediatric cohort (n=4) patients experienced major complications: (id no 25) re-operation 1 day after index procedure due to tethered cord and progressive neurologic deficit.The segmental spine instrumentation was removed.2nd re-operation 5 months after index procedure to proceed with instrumented t1-l3 fusion due to progression of deformity and back pain.The verse implant system was used for instrumentation.(id no 28) re-operation 1 month after index procedure due to surgical site infection (mrsa and e.Coli) requiring irrigation and debridement.(id no 33) table 12.Per patient complications in the pediatric cohort.Page 7 re-operation 2 weeks after index procedure for operative exploration and debridement of incision after marked murky serous drainage from the wound.Pseudomonas grew from wound cultures collected intra-operatively and an 8 week course of antibiotics was also prescribed.(id no 35) table 12.Per patient complications in the pediatric cohort.Page 7 re-operation 1.5 years after index procedure due to junctional kyphosis and instrumentation pullout.Partial removal of instrumentation and extension of the fusion to l4 was performed using the verse implant system.Adult cohorts , 11 patients experienced a major complications , 9 out of the 11 patients required re-operations , 3 out of the 11 patients experienced pseudoarthrosis: (id no 3) re-operation 2 months after index procedure due to nerve root irritation of the l5 nerve root from the sacral promontory screw requiring removal of l sided screw.(id no 4) re-operation 8 months after index procedure due to implant loosening and flat back deformity.The segmental spinal instrumentation was partially removed, the fusion was extended to s1, and a lateral extracavitary interbody fusion was performed.The expedium verse system was used.Re-operation 3.5 years after index procedure/ 3 years post 1st revision due to fractured implants and pseudoarthorsis.The segmental spinal instrumentation was partially removed, a kyphectomy was performed along with a corpectomy.The expedium verse system was used.(id no.5) re-operation 1 year after index procedure due to persistent pain in area of pelvic screws.The iliac screw and part of the rod was removed.(id no 7) rod breakage at one level 4.5 years after index procedure.At latest follow-up, no sequela or indication for re-operation.(id no 9) re-operation 1 year after index procedure due to painful bilateral segmental instrumentation at the s1-s2 segment.Re-operation 2 years after index procedure due to implant loosening, loss of correction, and pseudoarthrosis.The segmental instrumentation was partially removed and posterior instrumentation was performed l2-s2.Re-operation 2.5 years after index procedure due to pseudoarthrosis, instrumentation failure, and degenerative scoliosis.Combined anterior interbody fusion and posterior instrumented fusion was performed.(id no 14) fractured rods at t8-9 and t9-10 with evidence of pseudoarthrosis 4 years after index procedure.At latest follow-up, surgery was discussed as option for treatment.(id no 17) re-operation 3 years after index procedure due to implant prominence and pain.Bilateral removal of t8 screws was performed.(id no 26) re-operation 4 years after index procedure due to left sided rod pull back with prominence of the soft tissue.Partial removal of the segmental spinal instrumentation was performed along with excision of the bursa.(id no 29) re-operation 1 year after index procedure for removal of bilateral illiac screws due to pain.(id no 37) re-operation 10 months after index procedure to remove 2 upper screws on the right side due to prominence of the right rod compared to the left.(id no 54) removal of implants 1 year after index procedure due to severe and persistent back pain.There were no signs of pseudoarthrosis or implant prominence.The complication in the per treated cohort: (id no 32) re-operation 4 months after index procedure due to junctional kyphosis above her old fusion with severe pain.Posterior spinal fusion from c2-t5 was performed along with cervical tongs for traction and a halo vest.(id no 63) at 8 months post index procedure, upper right implant prominence was noted with recommendation for removal of the right proximal screw.At latest follow-up, it is unknown if patient moved forward with procedure.This is for depuy synthes expedium verse.This is report 4 of 9 for pc-(b)(4).

• Brand Name: UNK - CONSTRUCTS: EXPEDIUM VERSE
• 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 ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 14574666
• MDR Text Key: 293445520
• Report Number: 1526439-2022-00762
• 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: Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Initial Date Manufacturer Received: 05/03/2022
• Initial Date FDA Received: 06/02/2022
• 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