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

Device Problems Migration or Expulsion of Device (1395); Positioning Problem (3009)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

This report is being filed after subsequent review of the following journal article: treatment of unstable pelvic ring injuries with an internal anterior fixator and posterior fixation: initial clinical series, vaidya, r., colen, r., vigdorchik, j., tonnos, f., and sethi, a.J.Orthop & trauma: surgery 2012; 26:1-8.This article objective is to present a novel internal fixation device for stabilizing unstable pelvic fractures using supra-acetabular spinal pedicle screws and a subcutaneous connecting rod (infix).There were 24 patients with an average age of 40.3 years (range, 21-71years) with rotational or vertically unstable pelvic fractures.It is unclear if the synthes universal spine system or click-x and the use of c-rings were associated with the complications as the article failed to identify the devices associated with the complications.In the present clinical series, all fractures healed without significant loss of reduction.There were no infections, delayed union or nonunion.Male patient (b)(6) required repositioning of the pedicle screw and (b)(6) male required readjustment of screw rod junction.Both patient tolerated the procedure well and were fairly mobile after the procedure.Two male patients died (b)(6) in the early postoperative period secondary to multiple injuries and multisystem organ failure.This is report 1 of 4 for complaint (b)(4).This report is for an unknown pedicle screw.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Treatment of unstable pelvic ring injuries with an internal anterior fixator and posterior fixation: initial clinical series, vaidya, r., colen, r., vigdorchik, j., tonnos, f., and sethi, a.J.Orthop & trauma: surgery 2012; 26:1-8.This report is for an unknown spine screw( universal spine system or click-x).Additional product codes: nkb, mnh, kwp, kwq.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, PEDICLE SPINAL
• 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: 3899214
• MDR Text Key: 4429867
• Report Number: 2520274-2014-12127
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• 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: 06/06/2014
• 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: 64 YR