MAUDE Adverse Event Report: SYNTHES USA 6.2MM TI CLICK'X® PEDICLE SCR PREASSEMBLED 45MM THRD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 498.989

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

Patient Problems Pain (1994); Sedation (2368)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a patient had initial surgery on (b)(6) 2016, operating on levels l3 to l5 with the cick'x system.After the initial surgery, the patient's pain continued to persist.On (b)(6) 2016, the surgeon decided to revise the implanted cick'x system by extending the construct.There was a 20-30 minute surgical delay and the patient's status is stable.(initial surgery in (b)(4)) this report is 17 of 18 for (b)(4).

• Brand Name: 6.2MM TI CLICK'X® PEDICLE SCR PREASSEMBLED 45MM THRD LENGTH
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5983935
• MDR Text Key: 55836546
• Report Number: 2520274-2016-14723
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: PE
• PMA/PMN Number: K082572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 498.989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention