MAUDE Adverse Event Report: SYNTHES (USA) ACF TRIAL SPACER HANDLE; FORCEPS

Catalog Number 396.989

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

Patient Problems Paralysis (1997); No Code Available (3191)

Event Date 03/30/2017

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).Device is an instrument and is not implanted/explanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Without a lot number the device history records review could not be completed.The date of manufacture is unknown.Patient code (b)(4) was utilized for additional medical intervention due to reported event.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 during spine surgery to treat degenerative disc disease at levels c5 ¿ c6 on (b)(6) 2017, as the surgeon trialed a 6mm lordotic anterior cervical fusion (acf) spacer, it plunged into the spinal cord resulting in paralysis.The trail spacer was not broken.The surgeon pulled the trial spacer out and waited to see if there was a recurrence of sensation.There was initial paralysis in the patient¿s arms and legs.The patient had regained movement in arms with limited sensation in hands.Paralysis continues in left leg.The surgery was completed with c5-6 acdf with vectra plate and (ccacf) corticocancellous anterior cervical fusion with lordotic tissue graft procedure.There was a reported 30-45 minute surgical delay.The surgery was completed.The patient condition had not improved in past six (6) days (after (b)(6) 2017).The current condition of the patient is not available for reporting.This report is 1 of 2 for (b)(4).

• Brand Name: ACF TRIAL SPACER HANDLE
• Type of Device: FORCEPS
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6514199
• MDR Text Key: 73449098
• Report Number: 2520274-2017-11463
• Device Sequence Number: 1
• Product Code: HTD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 396.989
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR