MAUDE Adverse Event Report: SYNTHES USA TI PANGEA(TM) LOCKING CAP; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.620.000

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

Patient Problems Stenosis (2263); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient initials: (b)(6).Patient weight is unknown.Event date: unknown.Additional product codes: mni, mnh, kwp and kwo.(b)(4); lot unknown.Implanted: unknown date in 2010.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 that a patient had a t12-ilium posterior spinal fusion with synthes pangea and synthes iliosacral in 2010 on an unknown date.At an unknown point in time the patient developed stenosis and adjacent level disc disease cranial to the fusion; it was also reported the patient had pain, irritation or discomfort.On (b)(6) 2016 the surgeon performed the revision surgery to address the stenosis above the level of the fusion.The surgeon removed all the pangea hardware from t12-s1 and the synthes iliosacral from the ilium.There was no issue with the hardware from the 2010 surgery.A non-synthes construct was placed from t9 ¿ l2, decompression was performed from t9 ¿ t11 and the surgeon did not instrument the levels caudal to l2 as the patient has a solid fusion.The surgery was successfully completed with no surgical delay.This is report 2 of 4 for (b)(4).

• Brand Name: TI PANGEA(TM) LOCKING CAP
• 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: 5377568
• MDR Text Key: 36337954
• Report Number: 2520274-2016-10321
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK082572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.620.000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2016
• 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