MAUDE Adverse Event Report: SYNTHES (USA); ROD

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problems Non-union Bone Fracture (2369); Neck Pain (2433); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

This report is for 1 unknown rod where it was reported that on (b)(6) 2013 the surgeon performed a c2-t2 posterior cervical fusion with a synthes synapse 3.5mm rod system and decompression on the patient to address multi-level stenosis.On an unknown date, the patient returned to his clinic complaining of neck pain.Upon review of new imaging studies, the surgeon found that the patient had a broken right t1 screw and a nonunion.On (b)(6) 2014 the surgeon performed a revision surgery to remove the synapse rods and screws from the (b)(6) 2013 surgery.The broken segment of the right t1 screw remained in the patient as it was broken off deep in the pedicle.All the other hardware was removed.The surgeon then re-instrumented the existing screw holes from c2-c6 with synthes synapse 3.5mm rod system screws.He used 4.0mm diameter screws on the revision and explanted all the 3.5mm diameter screws.He placed synthes uss, universal spine system, screws from t1-t4 with the exception of the right t1 pedicle which was blocked by the synapse screw fragment.He then connected the 3.5 to 6.0mm tapered rods to the synapse and uss screws successfully completing the procedure.The product has not been returned for investigation and no further information was provided.This is report 2 of 3 for complaint (b)(4).

Manufacturer Narrative

Actual event date not known.This report is for 1 unknown rod.Additional product code for this report includes mnh, kwp, kwq.(b)(4).Investigation could not be completed and no conclusion could be drawn as the device was not returned and no lot number was provided.(b)(4).Placeholder.

• Type of Device: ROD
• Manufacturer (Section D): SYNTHES (USA); west chester PA
• Manufacturer Contact: s. o''malley ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3619143
• MDR Text Key: 4160388
• Report Number: 2520274-2014-00378
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2014
• 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: 01/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 94