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

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

Patient Problems Pain (1994); Weakness (2145); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.This report is for an unknown rod/unknown lot.Part and lot number are unknown; udi number is unknown.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.(b)(4).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: moshirfar a, jay khanna a, kebaish k (2007), treatment of symptomatic spondyloptosis in an adult previously treated with in situ fusion and instrumentation by l5 vertebrectomy and l4¿s1 instrumented reduction the spine journal, volume 7, pages 100-105 (usa) the purpose of this study is to present the first reported revision via the gaines procedure for failed fusion secondary to spondyloptosis.This is a case report of a (b)(6)-year-old woman with a long history of spondylolisthesis who had undergone multiple procedures for l5¿s1 spondylolisthesis and a final fusion and instrumentation attempt, presented with continued urinary retention, leg and back pain, and inability to stand.A two-stage procedure was initiated.In stage 1, hardware removal was done, and l5 corpectomy was performed.6 days later, the stage 2 procedure was performed.S1 was instrumented with 7-mm monoaxial moss miami (depuy acromed, raynham, ma) pedicle screws, and l3 and l4 were instrumented with 6.0 polyaxial moss miami pedicle reduction screws.Reduction then was achieved by using reduction screws in l4 and l3, by undercontouring the right and the left rods (which were fixed distally into s1), and by slowly reducing l4 on s1.Then 2 harms cages (15x12 mm, depuy acromed), packed with bone graft obtained from the vertebrectomy, were placed between l4 and s1.After wound closure, a wake-up test was performed while the patient was intubated.She was noted to have 0/5 strength in her tibialis anterior, extensor hallucis longus, and extensor digitorum longus muscles on the right side.The patient was anesthetized again, and the reduction between l4 and s1 was decreased.Despite decreasing the reduction between l4 and s1, the patient continued to have foot drop.A few days later, the patient was returned to the operating room after partial recovery (2/5 strength) of the tibialis anterior, extensor hallucis longus, and extensor digitorum longus, where she underwent repeat reduction of l4 to s1.Postoperatively, she maintained 2/5 strength in these muscle groups, was placed in lumbosacral orthosis with a left thigh cuff and was allowed to ambulate only from bed to chair.At 9 months follow-up, the patient had minimal back pain complaints, did not require pain medication, had no additional episodes of urinary retention, had complete recovery of her ankle dorsiflexion to 5/5.At the 2-year follow-up, she had full resolution of symptoms, full return of motor strength, and resolution of urinary retention.This report is for the 7-mm monoaxial moss miami (depuy acromed, raynham, ma) pedicle screws, 6.0 polyaxial moss miami pedicle reduction screws, rods, and harms cages (15x12 mm, depuy acromed).A copy of the literature article is being submitted with this medwatch.This report is for one unknown rod.This is report 3 of 4 for pc-(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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 is report 3 of 5 for (b)(4).

• Brand Name: UNKNOWN RODS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9497858
• MDR Text Key: 187378404
• Report Number: 1526439-2019-52738
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/26/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR