MAUDE Adverse Event Report: SYNTHES USA; WIRE, SURGICAL

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

Patient Problem Tissue Damage (2104)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following article: ringstrom, m., sullivan, h., fundell l., nigogosyan, m, (2007) a paradigm for staging screw-based spinal procedures: rationale, feasibility, safety, and efficacy.Journal of neurosurgery spine, volume 7, pages 521-532.Usa article.This was a retrospective study of 25 patients who had undergone transpedicular place holder k-wire fragment or screw placement in an interventional radiology (ir) setting between (b)(6) 2004 and (b)(6) 2006.The average age was 60 years (range 16-75 years), gender ratio (male/female) was 11:14.The mean postoperative period was 6.6 months (range 0.1-17.8 months).The objective of this study was to relate the rationale for and to describe the feasibility, safety, and efficacy of this stages two-procedure algorithm.The rationale for the new algorithm is unproven hypotheses regarding the potential benefits of the staging complex.Patients were treated with one of two procedural sequences.Each sequence consisted of two procedures: an outpatient interventional radiological procedure and an inpatient open surgical procedure.The first 19 patients had transpedicular k-wire fragments (axis tap, synthes), placed percutaneously in an interventional radiology (ir) setting, as placeholders for pedicle screws and pedicle screws (click¿x, synthes), and rods were placed days to weeks later in an open procedure in the operating room (or).The last 6 patients had pedicle screws placed without the rod-holding 3d head in an ir setting, and the rod-holding head and rods were placed days to weeks later in an open procedure in the or.A total of 126 thoracic and lumbar pedicles were implanted in the study.For unidentified patients- 2- k-wire fragment penetrations related to technical error (one case involved perforation of the anterior cortex of the vertebral body at t-4, the k wire was removed); the article did not provide details on the other k-wire fragment penetrations case.This is report 1 of 3 for (b)(4).This report is for: unknown number of k-wires fragments.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: (b)(4).This report is for an unknown k-wire fragments/unknown quantity/unknown lot.(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 were 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: WIRE, SURGICAL
• Manufacturer (Section D): SYNTHES USA; wrights 1302 lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4772119
• MDR Text Key: 5778733
• Report Number: 2520274-2015-13794
• Device Sequence Number: 1
• Product Code: LRN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• 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: 04/28/2015
• 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