MAUDE Adverse Event Report: SYNTHES USA; SCREW, FIXATION, BONE

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Unspecified Infection (1930); Impaired Healing (2378)

Event Date 06/11/2013

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article, "scalp necrosis following peroperative embolization for meningeal tumors: two cautionary tales" (2013).Kirkman, m.A., sethi, h., & kitchen, n.D.Acta neurochir, 15, 1413-1415.A report was done on preoperative embolization for meningeal tumors.In the report a (b)(6) female developed necrosis after a craniotomy that healed poorly and had serous discharge for several months.In two areas of the necrosis there was a synthes matrixneuro plate and screw protruding posteriorly and a synthes matrixneuro screw protruding anteriorly.The synthes matrixneuro plate and screws were subsequently explanted.This is report 3 of 3 for (b)(4).This report is for 1 unknown matrixneuro screw.

Manufacturer Narrative

Device used for treatment, not diagnosis.This report is for an unknown matrixneuro screw/unknown quantity/unknown lot.Without a lot number, the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: SCREW, FIXATION, BONE
• 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: 4356189
• MDR Text Key: 5222952
• Report Number: 2520274-2014-15538
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• 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?: No
• Date Manufacturer Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR