MAUDE Adverse Event Report: SYNTHES USA; POLYMETHYLMETHACRYLATE BONE CEMENT

Device Problem Leak/Splash (1354)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 02/03/2012

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for unknown pmma cement (traumacem v+, synthes)/unknown quantity/unknown lot.(b)(4).The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.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 subsequent review of the following literature article; krappinger d, kastenberger t.J, schmid.R (2012) using augmented instrumentation for the treatment of osteoporotic vertebral body fractures.Oper orthop traumatol 2012, 24: 4-12.The purpose of this study was repositioning and stabilization of osteoporotic vertebral body fractures using short-segment dorsal instrumentation, improvement of the screw purchase in osteoporotic bone by using cement augmentation of the pedicle screws to prevent postoperative correction loss and quick postoperative mobilization that is practically painless, without requiring external bracing.Between july 2008 and december 2009, 10 patients with osteoporotic vertebral body fractures of the cervical and lumbar spine were treated with cement-augmented instrumentation.The average age was 65.8 years (35-94 years).Type a injuries were involved in 6 cases (a1: 2 cases, a3: 4 cases) and type b injuries in 4 cases (b1: 1 case, b2: 1 case, b3: 2 cases).Pedicle screw system (uss ii, synthes) without central perforation in the screws or with perforated screws were used for instrumentation.Pmma cement was used for the cement augmentation (traumacem v, synthes or competitor's biomaterial).This report refers to the following complications: revision surgery due to loosened or severed pedicle screw and cement leakage in a (b)(6) female.The patient presented with post-traumatic kyphosis after a type a fracture of the 11th cervical vertebral body.Intraoperative image after corrective positioning of th9-th12 via dorsal instrumentation showed favorable alignment.Only the screws in the 9th cervical vertebral body needed to be augmented due to poor intraoperative screw purchase.Postoperatively loss of correction was reported due to the non-augmented pedicle screws severed by the 12th cervical vertebral body.Lengthening of the instrumentation, augmentation of the caudal pedicle screws and additional ventral support was performed during the revision surgery.Post-operatively cement penetration was reported in the paravertebral veins.This is report 4 of 6 for (b)(4).This report is for an unknown pmma cement (traumacem v+, synthes).A copy of the literature article is being submitted with this medwatch.

• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5090525
• MDR Text Key: 26270508
• Report Number: 2520274-2015-15867
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• 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: 09/08/2015
• 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: 55 YR