MAUDE Adverse Event Report: SYNTHES USA; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

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

Patient Problems High Blood Pressure/ Hypertension (1908); Cancer (3262)

Event Type  Injury  

Event Description

It was reported that a patient had a revision surgery to remove bilateral l3 pedicle screws in order to extend the fusion to l2/l3.It was reported that the patient had the original surgery in 2009.On (b)(6) 2014, the patient had revision surgery to remove the bilateral l3 pedicle screws in order to extend the fusion to l2/3.The patient was revised with adjacent level transforaminal lumbar interbody fusion (tlif) with a competitors construct.The patient was reported as stable at discharge.No time delay was reported.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for unknown unk - screw/unknown lot number.Without a lot number the device history record review and 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: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES USA; lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4401873
• MDR Text Key: 5127936
• Report Number: 2520274-2015-10171
• Device Sequence Number: 1
• Product Code: KWQ
• 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
• Type of Report: Initial
• Report Date: 12/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• 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: 12/14/2014
• 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
• Patient Age: 62 YR
• Patient Weight: 98