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

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

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Subject was included in the randomized control group; synthes is unable to precisely determine the manufacturer of their spine system implants.There were four (4) pedicle systems that were identified and approved in the study protocol for use as the control; however, no synthes manufactured products were referenced.Synthes did market a pedicle system at the time and the surgeon could have utilized this product.(b)(6).This report is for an unknown spine pedicle system/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported prodisc-l clinical study patient id (b)(6) was implanted with unknown fusion construct on an unknown date.Patient reported low back and leg pain, patient had hardware block on (b)(6) 2004 with excellent results.The severity of the adverse event reported was moderate, and the event was reported to be possibly related to the implant and the type of surgery.Course of action: on (b)(6) 2006, patient was hospitalized and hardware was removed at l4-l5.The set screws, rods and connectors were removed, the hardware was intact and the fusion was solid.The hardware was reported to be removed five (5) years post-operatively.This report is for an unknown spine pedicle system.This is report 1 of 1 for (b)(4).

• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: 5336455
• MDR Text Key: 34736902
• Report Number: 2520274-2015-18141
• Device Sequence Number: 1
• Product Code: NKB
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2007

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• 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?: No
• Date Manufacturer Received: 03/19/2007
• 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