MAUDE Adverse Event Report: SYNTHES USA; POLYMETHYLMETHACRYLATE BONE CEMENT

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Kohlhof h., seidel u., hoppe s., keel m.J., benneker l.M.(2013) cement-augmented anterior screw fixation of type ii odontoid fractures in elderly patients with osteoporosis.The spine journal 13 (2013) 1858¿1863.This report is for unknown pmma cement ((b)(4))/unknown quantity/unknown lot.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; kohlhof h., seidel u., hoppe s., keel m.J., benneker l.M.(2013) cement-augmented anterior screw fixation of type ii odontoid fractures in elderly patients with osteoporosis.The spine journal 13 (2013) 1858-1863.This article presents the retrospective review of hospital and outpatient records as well as radiographs of 24 elderly (8 males and 16 females; mean age, 81 years; range, 62-98 years) patients treated in a university hospital for type ii fractures of dens.To purpose of this study was to improve the stability of odontoid fracture screw fixation in the elderly using a new technique that includes injection of polymethyl-methacrylat (pmma) cement into the c2 body.After closed reduction and anterior approach to the inferior border of c2, a guide wire was advanced to the tip of the odontoid under biplanar fluoroscopic control.Before the insertion of one cannulated, self-drilling, short thread screws, a 12 gauge yamshidi cannula was inserted from anterior and 1 to 3 ml of high-viscosity pmma cement (vertecem, synthes) was injected into the anteroinferior portion of the c2 body.During polymerization of the cement, the screws (unknown manufacturer) were further inserted using a lag-screw compression technique.The cervical spine was then immobilized with a soft collar for 8 weeks postoperatively.At 6-month follow-up, none of the patients complained of relevant pain in the cervical spine.Anatomical reduction of the dens was achieved in all 24 patients.All patients returned to pretraumatic activity levels, and none experienced neurologic impairment.This report refers to the following complication: asymptomatic cement leakage in 4 patients: two patients had leakage of the cement into the c1/c2 joint, two had leakage into the fracture.None of these patients required revision.This is report 1 of 4 for (b)(4).This report is for an unknown pmma cement ((b)(4), synthes).

• 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: 5161710
• MDR Text Key: 28748727
• Report Number: 2520274-2015-16502
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: No
• 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: 10/02/2015
• 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