MAUDE Adverse Event Report: SYNTHES USA; ORTHOSIS, SPINAL PEDICLE FIXATION

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ossification (1428); Pain (1994); Post Operative Wound Infection (2446)

Event Date 02/09/2012

Event Type  Injury  

Event Description

This report is being filed after subsequent review of the following journal article, jones, c., sietsema, d.And hoffmann, m.(2012, february).Can lumbopelvic fixation salvage unstable complex sacral fractures?.Clin orthop relat res, 470, 2132-41.The authors retrospectively reviewed 15 patients with unstable sacral fractures treated with lumbopelvic fixation using synthes device, universal spine system, and sacroiliac screw of competitor if insertion was anatomically able between 2002 and 2010.The authors assessed reduction quality and loss of fixation, pain related to prominent hardware, subjective dysfunction and complications.There were seven males and eight females with mean patient age of 39 years (range, 16-68 years) and mean body mass index (bmi) of 28 kilograms per meter squared (range, 21-39 kilograms per meter squared).Patients were evaluated at regular and consistent intervals with minimum follow-up of 12 months (mean, 23 months; range, 12¿41 months).The authors reported the following: a 32 year old female experienced infection requiring operative debridement and antibiotic administration, heterotopic ossification and prominent hardware reported as palpable and painful; a 32 year old female underwent isolated unilateral lumbopelvic fixation and experienced loss of fixation and subsequent nonunion.She was treated with revision surgery and bone grafting; a 68 year old female experienced heterotopic ossification; a 39 year old female experienced prominent hardware reported as palpable and painful; a 41 year old male experienced prominent hardware reported as palpable and painful; a 17 year old male experienced prominent hardware reported as palpable and painful and infection requiring operative debridement and antibiotic administration.In addition: posterior reduction with less than 5 millimeter (mm) persistent displacement (11 patients) and five to ten mm persistent displacement (four); acetabular height difference of more than 10 mm without clinical leg length discrepancy (six); four patients were unable to return to similar work and or activities.Persistent reduction in daily activity, emotional, mobility, dysfunction and bother outcome measurements was reported compared with normative data.Lastly, screw loosening occurred in two patients; neither was symptomatic and neither had surgical revision.This is a serious injury report for a 32 year old female who experienced infection requiring operative debridement and antibiotic administration, heterotopic ossification and prominent hardware reported as palpable and painful.This report is for an unknown universal spine system.This is report 1 of 8 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for an unknown universal spine system.(b)(4).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: ORTHOSIS, SPINAL PEDICLE FIXATION
• 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: 3996787
• MDR Text Key: 4953174
• Report Number: 2520274-2014-12727
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2014
• 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: 32 YR