MAUDE Adverse Event Report: SYNTHES USA TI MATRIX LOCKING CAP; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.632.000

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

Patient Problems Pain (1994); Vascular System (Circulation), Impaired (2572); No Code Available (3191)

Event Type  Injury  

Event Description

It was reported that the tulip popped off of the matrix screw.On (b)(6) 2014 the surgeon performed a minimally invasive transforaminal lumbar interbody fusion (tlif) from a mini open incision on the left posterior side.The levels involved were l4-l5.The surgeon implanted a vertebral spacer tr, 10x30x10mm and used four 6.0mm titanium cannulated matrix polyaxial screws, four titanium matrix locking caps, and two 5.5mm titanium curved rods 35mm.During the one month post-op follow-up visit, the surgeon took x-rays, date unknown.The surgeon noticed the head of one screw came off and the spacer has migrated.The surgeon decided to leave the devices implanted and monitor it.The patient status was listed as neurologically intact.There was no reported complaint of pain, nor any other pathological issues reported.On (b)(6) 2014, the patient went for a post-operative visit.The patient did not have leg pain at that time.X-rays taken during the post-operative visit showed a disconnection between the two head and the screw, a pedical screw was fractured and the cage had backed out.At that point, the surgeon decided to monitor the patient and not proceed with a revision procedure.On (b)(6) 2014, the patient went for another post-operative visit.She had started to experience lower back pain and right hip pain with occasional tingling in the right leg.At this point the surgeon decided to proceed with a revision procedure on (b)(6) 2014.It was reported that the patient underwent a procedure on (b)(6) 2014.The procedure performed was an exploration of l4-5 fusion area with removal and reinsertion of instrumentation, decompression of nerve root and removal of old inter-body graft fusion, both inter-body and posterolateral with inter-body device and allograft mixed with bone marrow aspiration.The l4 screw head and nut was disconnected and the rod was removed.This allowed for exposure of the broken l5 screw with the head still visible.The cage was identified lateral to the interspace and had backed out.Loose fragments of the old bone graft were removed.The patient was implanted with one screw, one spacer, one rod, two locking caps, chronos granules and putty.The patient was discharged on (b)(6) 2014 and it was noted that the patient had immediate improvement in her right leg pain, improvement in her lower back pain and was able to ambulate without difficulty.There was no delay in surgery and it was reported that the patient recovering with no additional harm.In (b)(6) 2015, it was reported that the patient is currently experiencing leg and circulation problems.It was reported that she will have an unknown shot on (b)(6) 2015 to treat this.It was reported that the patient is still in pain; every step she takes hurts.The patient had another unknown shot in her leg on (b)(6) 2015.This is report 13 of 13 for (b)(4).

Manufacturer Narrative

(b)(6).Additional product codes: mnh, mni, kwq, kwp.Device has not been reported as explanted.(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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Date of this report/ date received by manufacture reported as april 14, 2014; should be april 14, 2015.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TI MATRIX 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: 4733706
• MDR Text Key: 5739040
• Report Number: 2520274-2015-13464
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.632.000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2015
• 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: 86