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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Cerebrospinal Fluid Leakage (1772); Failure of Implant (1924); Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article: vereijken, i.M.P.And de kleuver, m.(2013).Late proximal pedicle hook migration into spinal canal after posterior correction surgery of scoliosis causing neurologic deficit: ¿proximal junctional scoliosis¿? case series and review of the literature.Spine deformity 1 (2013) 229-236.This was retrospective review of 800 scoliosis correction procedures performed between january 2002 and april 2012 using universal spine system (uss).Limited data was provided for the 800 patients.However, specific population data was provided for 5 of the patients who presented with symptomatic proximal hook dislodgement between april 2009 and march 2010.The study population of these 5 patients included: patient 1, (b)(6) male; patient 2, (b)(6) male; patient 3,(b)(6) female, patient 4, (b)(6) female and patient 5 was a female however her age was not provided.Four of the five patients had adolescent idiopathic scoliosis and developed symptomatic medical proximal pedicle hook migration into the spinal canal late (>12 months) after posterior correction surgery of scoliosis.Patient 5 was not included in the study because she had a movement disorder and presented 3 months post-operatively with cervicobrachialgia and medial migration of the proximal pedicle hook.The authors noted the neuromuscular disorder may have contributed to the dislodgement, however this will be captured as an event.The 4 patients that were discussed in more detail had posterior correction surgery.Patients were symptomatic 19-78 months after the primary surgery.All 4 of these patients had pain after a period of not having any problems.Radiographic images showed progressive medial migration of the proximal left pedicle hook.Spinal fusion was evident radiographically.These 4 patients had revision surgery in which the migrated hook was removed and the instrumentation was re-explored.Three of the 4 patients had a cerebrospinal fluid (csf) leak which was treated with another manufacture¿s product.Pain symptoms resolved after the revision surgery in all patients.This report is for (b)(4) and includes the following events: patient 1: male, (b)(6) had posterior correction surgery of the scoliosis at t5-l1 (instrumentation and fusion).At 28 months post-op, had pain after a period of no problems; radicular left flank pain with an antalgic gait and right-anterior stooped position.Left proximal hook migration at t5, 28 months post-op.Had migrated hook removed and the proximal part of the rod was removed.Revised to transverse connector.During revision surgery, had csf leak which was repaired and resolved.This is report 1 of 8 for (b)(4).This report is for an unknown uss hook.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Literature citation: vereijken, i.M.P.And de kleuver, m.(2013).Late proximal pedicle hook migration into spinal canal after posterior correction surgery of scoliosis causing neurologic deficit: ¿proximal junctional scoliosis¿? case series and review of the literature.Spine deformity 1 (2013) 229-236.This report is for an unknown quantity of a uss hook with an unknown part and lot number.(b)(6).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.

• Type of Device: ORTHOSIS, PEDICLE SPINAL 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: 4295423
• MDR Text Key: 5081697
• Report Number: 2520274-2014-15046
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• 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?: Yes
• Date Manufacturer Received: 11/07/2014
• 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: 16 YR