MAUDE Adverse Event Report: SYNTHES USA

Device Problems Device Slipped (1584); Malposition of Device (2616)

Patient Problems Pulmonary Embolism (1498); Death (1802); Failure of Implant (1924); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Respiratory Distress (2045); Thrombosis (2100); Heart Failure (2206); Brain Injury (2219); Discomfort (2330)

Event Date 05/24/2011

Event Type  Injury  

Event Description

Abstract received: a minimally invasive stabilizing system for dorsal pelvic ring injuries; thomas dienstknecht, md, arne berner, md, andreas lenich, md, michael nerlich, md, bernd fuechtmeir, md;clinical orthopaedics and related research (2011) 469: 3209-3217; reported: open reduction and stabilization of dorsal pelvic ring injuries is accompanied by a high rate of soft tissue complications.Minimally invasive techniques have the potential to decrease soft tissue trauma, but the risk of iatrogenic nerve and vessel damage through the reduced surgical exposure should be considered.We treated these injuries using a transiliac internal fixator in a minimally invasive technique characterized by implantation of a pedicle screw and rod system, bridging the sacroiliac joints and the sacral area.We asked whether (1) we could achieve anatomic restoration with the device, (2) specific complications were associated with this minimally invasive approach, and (3) function 3 years after trauma was comparable to that of established methods.The authors retrospectively reviewed 67 patients who underwent minimally invasive reduction and fixation of a dorsal pelvic ring injury between (b)(6) 2000 and (b)(6) 2007.The mean patient age at the time of surgery was 36.7 years (range, 16-76 years).Twenty-nine patients were female, and 38 were male.The indications for surgery were: (1) sacroiliac displacement and (2) sacral fractures.This abstract mentions the use of pedicle screws (universal spine system, synthes, (b)(4)), the connection bar) 6-mm diameter, universal spine system, synthes) and the distraction/compression device from the universal spine system, synthes.Results: five of the 67 patients did not complete follow-up: two died during the early postoperative period (one owing to traumatic brain injury and the other from heart failure), and three moved away or were not available for reevaluation owing to personal reasons.At last follow-up the authors observed a secondary fracture displacement greater than 5mm in one patient.Four wound infections occurred during the first 4 weeks postoperatively, all in patients with polytrauma and long-time ventilation.One malpositioned screw was identified without any consequences to the healing process and one secondary displacement attributable to implant failure.Two patients had deep vein thrombosis with secondary pulmonary embolus.Thirteen patients had acute respiratory distress syndrome develop, with a maximum stay in the intensive care unit of 66 days.Twelve patients reported mild local discomfort when in the supine position, in the region of the posterior superior iliac spine that was relieved by standing or walking; the complaints diminished after implant removal.One patient had asymptomatic screw loosening, which was identified during implant explantation.Fifteen patients (four with complex pelvic ring injuries) had minor restrictions and eight (four with complex pelvic ring injuries) had intermittent pain during mobilization.Two patients experienced permanent pain and incontinence immediately after trauma occurred.Four patients with complex pelvic ring injuries had severe discomfort and restriction with urologic dysfunction, and three had permanent incontinence.Conclusion: the observations made suggest transiliac internal fixator is a reasonable alternative to other established fixation devices for injuries of the dorsal pelvic ring with minor risks of major blood loss or iatrogenic neurovascular damage.This report is on an unknown transverse bar, quantity is unknown.This is 5 of 5 reports for (b)(4).

Manufacturer Narrative

This device used for treatment and not diagnosis.Additional device info: this report is on an unknown transverse, part and lot numbers are unknown.Date of event: 2011.Pma/510(k): without a part number the 510k number cannot be provided.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.Placeholder.

• Manufacturer (Section D): SYNTHES USA; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3650909
• MDR Text Key: 16804859
• Report Number: 2520274-2014-00866
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• 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: 01/31/2014
• 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