MAUDE Adverse Event Report: SYNTHES USA; TRACTION, COMPONENT, INVASIVE

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

Patient Problems Pain (1994); Burning Sensation (2146); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Wiznia, d.H., et al (2016) a method of using a pelvic c-clamp for intraoperative reduction of a zone 3 sacral fracture.Hindawi publishing corporation, case reports in orthopedics, volume 2016, article id 8586517, 5 pages.This report is for unknown pelvic c-clamp, 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

Literature article received.This report is being filed after the subsequent review of the following literature article: wiznia, d.H., et al (2016) a method of using a pelvic c-clamp for intraoperative reduction of a zone 3 sacral fracture.Hindawi publishing corporation, case reports in orthopedics, volume 2016, article id 8586517, 5 pages.A (b)(6)-year-old man suffered a pelvic ring injury and a comminuted proximal humerus fracture-dislocation in a motorcycle collision.A pelvic c-clamp was then applied over the s2 transsacral wire.Radiographs demonstrated an anatomic reduction.With the c-clamp holding the sacral fracture reduction, s1 transsacral screw was engaged into the far ilium allowing for more compression across the fracture site.An additional guide wire was passed at the s2 level for further stability.Another transsacral screw was placed across the fracture utilizing one of the s2 guide wires.The patient¿s hospital course was complicated by pneumonia and a deep vein thrombosis.The patient was discharged to short term rehabilitation on hospital day 30, with restrictions not to bear more than 25 pounds to the left lower extremity.At the patient¿s 8-week follow-up appointment, he complained of burning and numbness over the buttocks.At the patient¿s three-month follow-up, he complained of sacral and bilateral buttock pain, as well as sexual dysfunction.At a recent 3-year follow-up the patient is weight bearing as tolerated without restriction.He has returned to motorcycling.This is report 1 of 1 for (b)(4).This report is for an unknown pelvic c-clamp.

• Type of Device: TRACTION, COMPONENT, INVASIVE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6522393
• MDR Text Key: 73716126
• Report Number: 2520274-2017-11526
• Device Sequence Number: 1
• Product Code: JEC
• 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,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 03/31/2017
• Initial Date FDA Received: 04/26/2017
• 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: 44 YR