MAUDE Adverse Event Report: SYNTHES MONUMENT TI LOCKING SCREW; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 04.614.508

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

Patient Problems Fatigue (1849); Foreign Body Sensation in Eye (1869); Headache (1880); Unspecified Infection (1930); Pain (1994); Dizziness (2194)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Date infection began is not known.Additional product codes: kwp, mnh, mni.(b)(4) lot unknown.Device has not been reported as explanted.Complainant part is not expected to be returned for manufacturer review/investigation.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 underwent two (2) prior revisions of competitor¿s hardware for anterior cervical fusion (acf) on (b)(6) 2016.After seeking treatment from another surgeon, patient was then implanted with synthes hardware: two (2) 3.5 mm titanium curved rods, four (4) 3.5 mm titanium cancellous polyaxial screws, and four (4) titanium locking screws.Patient was also implanted with an unknown spacer; it is not believed the spacer is a synthes product.Two (2) weeks following implant procedure, patient reports hearing a loud pop.An unplanned follow up visit to the surgeon revealed patient had an incisional infection.Patient was treated with oral antibiotics and told to use ice and heat for the pop and pain.Patient reports continued incisional pain, dizziness, fatigue, and headaches.Patient further reports being able to feel the implant if tilting her head back.Patient continues to be treated with hydrocodone and valium, and was schedule for a computed tomography (ct) scan on (b)(6) 2017.Devices remain implanted at this time.Concomitant devices reported: spacer (quantity 1).This report is for one (1) ti locking screw.This is report 9 of 10 for (b)(4).

• Brand Name: TI LOCKING SCREW
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6744269
• MDR Text Key: 81054485
• Report Number: 1719045-2017-10700
• 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: other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.614.508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2017
• Initial Date FDA Received: 07/26/2017
• 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: SPACER (PART AND LOT UNKNOWN, QTY 1)
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 64