MAUDE Adverse Event Report: SYNTHES BRANDYWINE 3.5MM TI CORTEX POLYAXIAL SHAFT SCREW 24MM F/4.0MM RODS; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 04.615.324

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: patient identifier not available for reporting.Patient date of birth reported as (b)(6) 1948.Date of non-union and device breakage.Additional product codes: kwp, mnh, mni.(b)(4).Date of implant reported as (b)(6) 2016.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant devices therapy date reported as (b)(6) 2016 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 patient was implanted with three synapse screws during a posterior cervical fusion on or about (b)(6) 2016.During a post-operative visit it was noted patient had a nonunion.Surgeon did not plan to revise the patient at that time.Patient later suffered a post-operative fall on an unknown date and was subsequently returned to surgery on (b)(6) 2017.During the revision procedure it was noted that the head of one of the synapse shaft screws had popped off postoperatively.The screw head fragment was easily removed.A screwdriver was used to easily remove the embedded screw shaft.A second 3.5mm x 24mm synapse shaft screw and a 3.5mm x 14mm synapse screw were also removed easily and intact.Patient was revised to three (3) larger diameter screws, two (2) were synapse screws and the third a depuy spine expedium screw.Surgery was completed successfully with no delay and no harm to patient.Patient reported as stable following surgery.Concomitant devices reported: 3.5mm x 24mm synapse screw (part number unknown, lot number unknown, quantity 1), 3.5mm x 14mm synapse screw (part number unknown, lot number unknown, quantity 1).This report is for one (1) 3.5mm cortex polyaxial shaft screw.This is report 1 of 1 for com-(b)(4).

• Brand Name: 3.5MM TI CORTEX POLYAXIAL SHAFT SCREW 24MM F/4.0MM RODS
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6634797
• MDR Text Key: 77378280
• Report Number: 2530088-2017-10195
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142838
• 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: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.615.324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2017
• 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
• Treatment: 14MM SCREW (PART AND LOT UNKNOWN, QTY 1); 24MM SCREW (PART AND LOT UNKNOWN, QTY 1)
• Patient Outcome(s): Required Intervention
• Patient Weight: 76