MAUDE Adverse Event Report: SYNTHES USA 6.0MM TI COLLAR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 498.010

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

Patient Problems Irritation (1941); Pain (1994); Discomfort (2330); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Patient weight is unknown.Additional product codes for this report include mni, mnh, kwp, and kwq.(b)(4).Date of original implant procedure is unknown.Per facility, the complainant parts were returned to the patient and are not available for manufacturer evaluation.(b)(4).Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.Device 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 underwent a posterior spinal fusion procedure from t10-l3 with synthes universal spine system (uss) instrumentation on an unknown date.Thereafter, the patient achieved a solid fusion at the t10-l3 level with no hardware related issues.At an unknown time, however, the patient developed junctional kyphosis above the level of fusion (t10 level) and stenosis below the level of fusion at the l5 level.Pain, irritation, and discomfort were also noted.As a result, the patient was returned to the operating room for revision on (b)(6) 2015.During the revision, the rods were removed and the purchase of all screws was checked.Eight (8) of the twelve (12) screws between t10 and l3 were removed and replaced with larger diameter uss screws.Also, new bilateral screws were placed at t7, t8, t9, l4, s1, and ilium.A decompression was performed at l4-l5 and new rods were contoured then connected from t7-ilium.The procedure was successfully completed.This report is 6 of 10 for (b)(4).

• Brand Name: 6.0MM TI COLLAR
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5363931
• MDR Text Key: 35801404
• Report Number: 2520274-2016-10191
• 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: Other
• Type of Report: Initial
• Report Date: 12/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 498.010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/28/2015
• 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