MAUDE Adverse Event Report: UNK - BIOMATERIAL - CEMENT: CONFIDENCE; POLYMETHYLMETHACRYLATE BONE CEMENT

Device Problem Chemical Problem (2893)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: this report is for an unknown biomaterial - cement/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: rustagi, t.Et al.(2020), floating vertebral body cement ball after high-viscosity-cement vertebroplasty for lytic defect: report of 2 cases, international journal of spine surgery, vol.14, no.4, pages 594-598 (india).This study describes 2 cases of high-viscosity cement (hvc) vertebroplasty resulting in a floating vertebral body cement ball as a complication and discuss its implications and prevention strategies.The procedure was performed under general anesthesia in the prone position; percutaneous vertebroplasty (pvp) was performed according to the method described by o¿brien et al.6 in both the cases, hvc was used (confidence, depuy spine, raynham, massachusetts).Case 1: an 89-year-old male with a known history of metastatic prostate cancer presented with worsening back pain of 1-month duration.Ct scan images showed a severe fracture involving the l1 vertebra with a cleft and mild retropulsion of bone into the spinal canal.Pvp was performed using a left-sided, transpedicular approach.Immediate postoperative ct scan showed that the cement did not interdigitate with the trabeculae and was lying in the cleft, connected through a long tail.Clinically, the patient had marked pain relief in the immediate postoperative period.A repeat ct scan after 3 days showed that the cement ball had moved.At 3 weeks follow-up, following an initial improvement in pain, the pain had again become severe to the extent that it was impeding his ambulation.Repeat x-rays and ct scan at this stage showed further collapse.The cement tail had fractured, and the cement mass had turned horizontally.Flexion-extension x-rays showed significant intravertebral instability.Following a detailed discussion with the patient, a posterior fusion surgery was done from t10 to l4.Afterward, the patient had good pain relief and was able to ambulate well.Case 2: a 68-year-old male with multiple myeloma and multiple spine metastasis presented with mechanical pain in the mid-thoracic region (vas score 8).Ct scan and x-ray images showed compression fractures of t7 and t8 with a large lytic defect involving the t8 vertebra.Hvc vertebroplasty was performed at both levels using transpedicular, unilateral approaches at both levels.At the t8 level, after around 10 minutes of injection, an initial attempt to withdraw the trocar was unsuccessful.The trocar was noted to be stuck to the cement.The cement mass itself was not interdigitated with the trabeculae and was turning freely with the rotation of the trocar.After repeated forced twisting, the trocar was detached.The cement ball itself had rotated by this time.The patient had significant pain relief from the procedure.Subsequent x-rays and ct scan showed stable cement position.This report is for an unknown depuy spine confidence.

Manufacturer Narrative

Product complaint # (b)(4).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: d1: impacted product updated: h3, h6: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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.

• Brand Name: UNK - BIOMATERIAL - CEMENT: CONFIDENCE
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• MDR Report Key: 12468617
• MDR Text Key: 271301868
• Report Number: 1526439-2021-02001
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• 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