MAUDE Adverse Event Report: SYNTHES USA 6.0MM TI CANN MATRIX POLYAXIALSCREW 40MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.606.640

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

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

Event Type  Injury  

Event Description

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.On (b)(6) 2015, it was noted the patient was experiencing leg and circulation problems and was having an unknown shot in her left knee on (b)(6) 2015.This is report 4 of 9 for com-052788.

Manufacturer Narrative

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.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 the patient is still in pain; every step she takes hurts.The patient had another unknown shot in her leg on (b)(4), 2015.This is report 4 of 13 for (b)(4).

• Brand Name: 6.0MM TI CANN MATRIX POLYAXIALSCREW 40MM THREAD 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4719300
• MDR Text Key: 17934690
• Report Number: 2520274-2015-13311
• 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: 04/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.606.640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2015
• 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