MAUDE Adverse Event Report: DEPUY SPINE INC UNKNOWN BIOMATERIAL - CEMENT; POLYMETHYLMETHACRYLATE BONE CEMENT

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Stenosis (2263); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.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.(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: wu c, lee cy, huang tj, wu mh (2019), full-endoscopic lumbar foraminoplasty for symptomatic cement leakage with exiting nerve root impingement, world neurosurg., volume 132, page 253-257, (taiwan).This study reports a case of symptomatic cement leakage treated with full-endoscopic lumbar foraminoplasty (felf) with the patient under local anesthesia.This is a case report of an (b)(6) year-old woman who was admitted because of lower back pain.3 months ago, the patient had undergone percutaneous vertebroplasty for an l3 compression fracture using high-viscosity cement unknown depuy spine confidence spinal cement system.The patient then presented with lower back pain and new onset left thigh pain after vertebroplasty.She was unable to walk or to lie flat on her back.A femoral stretch test of her left leg revealed positive findings.Her back-pain score was 78% on the oswestry disability index because of her crippling condition, which had affected all aspects of her life.Her visual analog scale (vas) score for pain was 8 to 9 for her left leg.The patient¿s self-rated health, measured using the euroqol group vas, was 30 of 100.Preoperative magnetic resonance imaging showed a previous compression fracture with cortical disruption at the lower vertebral body with extension to the l3-l4 foramen.A radiograph and computed tomography scan showed cement leakage to the l3-l4 foramen from the cortical disruption.The patient had to undergo revision surgery with the removal of cement.A t12 percutaneous bipedicular vertebroplasty was then performed.After the vertebroplasty, left-side full-endoscopic lumbar foraminoplasty was performed with the patient under local anesthesia.The postoperative radiograph showed global alignment in the spine and the successful removal of the cement fragment.The patient had experienced immediate pain relief after surgery and was discharged 4 days after the operation.Her postoperative vas score was 1.Furthermore, after surgery, she was able to walk.At 1 month postoperatively, she reported significant improvement in her vas score (from 8 to 9 to 1), oswestry disability index (from 78% to 20%), and euroqol group vas (from 30 to 85).This report is for the unknown depuy spine confidence spinal cement system.This report is for one (1) unknown cement.This is report 1 of 1 for (b)(4).

• Brand Name: UNKNOWN BIOMATERIAL - CEMENT
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 10118904
• MDR Text Key: 194939402
• Report Number: 1526439-2020-01110
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2020
• 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: 85 YR