MAUDE Adverse Event Report: SYNTHES (USA) 4.0MM TI ROD 120MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 04.615.526

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

Patient Problems Fatigue (1849); Neuropathy (1983); Positive antinuclear antibodies (ANA) (2015); Rash (2033); Chills (2191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Patient age and weight are not available for reporting.The date patient¿s symptoms began is unknown but reportedly began soon after initial implant date of (b)(6) 2015.(b)(4).The subject device is still reportedly implanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.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.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 on an unknown date, soon after the patient underwent a cervical fusion c2-t2 laminoplasty on (b)(6) 2015, the patient developed a rash along his neck, fatigue, flushing, chills, and has experienced increased neuropathy.It was further reported that since the surgery, the patient feels generally unwell and has tested positive for antinuclear antibodies (ana).This report is 26 of 26 for (b)(4).

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.

• Brand Name: 4.0MM TI ROD 120MM
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5631119
• MDR Text Key: 44403109
• Report Number: 2520274-2016-12529
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• PMA/PMN Number: PK142838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 04/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.615.526
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2016
• 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