MAUDE Adverse Event Report: SYNTHES (USA); ORTHOSIS, SPINAL PEDICLE FIXATION.

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

Patient Problems Bone Fracture(s) (1870); Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

This report is for 1 unknown screw, where it was reported that a revision surgery was performed due to the patient experiencing pain, coronal imbalance and a t8 compression fracture at the level of the hardware.The patient originally underwent a t10-illium posterior spinal fusion in (b)(6) of 2013, exact date unknown.The surgeon used a ti uss, universal spine system, dual opening and uss vas iii with 2 screws.On an unknown date, the patient complained of ongoing thoracic pain and coronal imbalance, the patient walks leaned over to the side to compensate.It is not reported as to how the surgeon discovered the patient developed a t8 compression fracture above the levels of the hardware.It was reported that there was no issue with the hardware.The surgeon decided to perform a two stage surgery in which, stage one took place on (b)(6) 2014.All rods, collars and nuts were explanted.An unknown amount of screws remained in the patient.The surgeon then checked all the screws to ensure that they are securely anchored in the bone and replaced the unknown amount of screws that were loose with larger screws.The surgeon then instrumented the levels above the previous fusion to t4 using the dss dual opening.The explanted devices will not be returned.All item numbers for the explanted devices have been reported with the exception for an unknown amount of 499.2xx series screws and two 499.3xx series screws.It was further reported that the amount of screws implanted and explanted is unknown and the patient did not have screws at every level.The second surgery was completed on (b)(6) 2014, whereby the surgeon performed an l3 pedicle subtraction osteotomy as well as ponte osteotomies to correct the patients coronal imbalance.The surgeon then connected the new rods from t4-illium with the screws placed in stage one.This second surgery was completed successfully with no issue.The product has not been returned for investigation and no further information was provided.This is report 3 of 10 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date of event: actual event date not known.Additional device info: this report is for 1 unknown screw.Common device name: additional product code for this report includes mnh, kwp, kwq.Implant date: implant on unknown date in (b)(6) 2013.Investigation could not be completed and no conclusion could be drawn as the device was not returned and no lot number was provided.Placeholder.

Manufacturer Narrative

Device is used for treatment, not diagnosis.This report is for an unknown quantity of uss dual opening screws of part family 499.2xx.

• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION.
• Manufacturer (Section D): SYNTHES (USA); west chester PA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3647372
• MDR Text Key: 16913484
• Report Number: 2520274-2014-00809
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• 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: 03/25/2014
• 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: 72 YR
• Patient Weight: 64