MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; POLYMETHYLMETHACRYLATE BONE CEMENT

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Nerve Damage (1979); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: this report is for one (1) unknown vertecem.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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: hoppe s, et al (2016).Lordoplasty: midterm outcome of an alternative augmentation technique for vertebral fractures.Journal of neurosurgery: spine.Volume 24.Number 6.Pages 922-927.(switzerland).The aim of this retrospective study was to analyze the midterm results of the case series of patients treated with lordoplasty.Between 2002 to 2014, 65 patients (46 women, 19 men, age range 38.9¿86.2 years old) who were treated with lordoplasty vertebral compression and insufficiency fractures, were included in the study.In 4 patients, lordoplasty was performed at 2 adjacent levels; thus a total of 69 vertebrae was treated.In all cases, standard polymethylmethacrylate cement, unknown synthes vertecem, was used.The occurrence of cement leakage and incidence of new vcf were evaluated based on postoperative radiographs.Clinical assessment on surgical duration and frequencies of complications and reoperations were captured.The mean follow-up duration was 33 months (range 24¿108 months).Complications were reported as follows: 6 vertebrae had cement leakage into segmental veins or paraspinous tissue.A (b)(6) woman with type a 3.1 fracture of t-12 showed a cement leakage through the fracture gap that was symptomatic, causing an irritation of the twelfth intercostal nerve.Patient was treated with local anesthetics and steroids, which led to an immediate and lasting pain relief.A (b)(6) woman with a severe osteoporotic l-1 compression fracture who had lordoplasty at l-1 and adjacent augmentation of t-12 and l-2 developed an adjacent compression fracture of t-11 at 3 years post-op; 23 patients required 28 secondary interventions on the spine after the lordoplasty during the cumulative observation period of nearly 9 years.Indications for new surgery were as follows: 16 patients developed a new distant osteoporotic fractures, 7 patients developed a new adjacent osteoporotic fractures, 4 patients had an instrumented fusion due to instability, 1 patient had a new adjacent traumatic fracture, 1 patient reported no reduction of pain, 2 patients remained dependent after surgery and required further conservative therapy due to chronic, immobilizing back pain.A marginal loss of reduction (0.3°) of the mean vertebral kyphotic angle (vka) was noted at the latest follow-up evaluation.The mean current level of back pain was 2.1 points (range 1¿7 points) on the visual analog scale.This report is for one (1) an unknown vertecem.(b)(4).

• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7778215
• MDR Text Key: 117003110
• Report Number: 8030965-2018-55679
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• 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: 07/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR