MAUDE Adverse Event Report: SYNTHES USA 8.0MM TI SIDE-OPENING ILIAC SCREW 100MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 498.874

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Original implant date reported only as (b)(6) 2015 (day 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 a patient underwent a posterior t10 - ilium spine fusion with synthes universal spine system (uss) in (b)(6) 2015 to treat kyphoscoliosis and stenosis.The patient was reported to have kyphosed above the construct.The patient was returned to the operating room (or) on (b)(6) 2015 where the construct was extended to t4.The patient reported increasing lower back pain.Images taken on unknown date revealed two broken rods just caudal to the l4 screws and a non-union from l4 - s1.The patient was again returned to the or on (b)(6) 2015 where the surgeon removed the rods that spanned from t10 to ilium, all screws from t11 - s1, and the right iliac screw.It was noted these screws were loose in the bone.The left iliac screw was not removed; the collar and nut were removed.All screws were replaced with larger diameter screws.The surgeon then cut and contoured new pre-contoured rods and connected the rods to the extension connectors and the new screws.The procedure was completed successfully with no delay and no further harm to patient.This is report 18 of 18 for com-145613.

• Brand Name: 8.0MM TI SIDE-OPENING ILIAC SCREW 100MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES USA; 1032 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5261643
• MDR Text Key: 32576785
• Report Number: 2520274-2015-17636
• 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: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 498.874
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2015
• 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 Weight: 51