MAUDE Adverse Event Report: SYNTHES USA; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for two unknown click x screws/unknown lots.Part and lot numbers are unknown; udi number is unknown.Additional product codes: mnh, mni, kwp, kwq.It was reported the 2 click x screws were not explanted during the revision procedure.(b)(4).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 original surgery was performed on unknown date using the click x for a posterior lumber inter-body fusion (plif) construct at l4-l5 disc level.Due to adjacent level disc disease the patient was revised on (b)(6) 2015.Construct was extended to include the l3-l4 disc levels.The surgeon left unknown click x screws from the original construct in place at the l4-l5 disc level.The original two rods and trans-connector were removed and replaced with longer rods and additional screws at the l3-l4 level.During the revision surgery while the surgeon was instrumenting at the l4-l5 disc level, the tip of the screwdriver broke off.When removing the trans-connector between the two rods the surgeon applied pressure to the recess.A fragment was generated and retrieved by the surgeon.Another driver was available in the operating room to complete the procedure.Due to this event no additional time was added and revision surgery was completed successfully with no patient harm; the patient status was reported as good.This report is for two unknown click x screws.This is report 1 of 6 for (b)(4).

• 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: 5350255
• MDR Text Key: 35242647
• Report Number: 2520274-2016-10083
• 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: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• 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: 12/17/2015
• 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