MAUDE Adverse Event Report: SYNTHES USA; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).This report is for one (1) unknown rod.Part#, lot# and udi # is not available.Initial implant procedure was done in (b)(6) 2015.Exact date is unknown.Device is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 that an initial procedure was performed in (b)(6) 2015 to address a sacral fracture that occurred as a result of a motorcycle accident to the patient.Originally implanted hardware was on the right side of the spine from l5-ilium, using two (2) screws, two (2) collars, two (2) nuts, and one (1) rod from the universal spine system (uss) set.No screw was implanted at s1 disc level.At an unknown point in time, the patient did not heal and develop a non-fusion.Also, the rod broke at the l5 disc level.A revision surgery was performed on (b)(6) 2017.Surgeon removed the rod, and then removed the l5 disc screw due to that fact that he thought it was a little loose and replaced it with one inch diameter size bigger screw.Surgeon left the iliac screw intact.Surgeon then contoured a new rod and connected it to the right l5 and right iliac screw position.Surgery was completed successfully and patient was reported in stable condition.Concomitant medical products: 6.0mm titanium collar (part# 498.010, lot# unknown, quantity 2); titanium nut 11mm width across flats (part# 498.003, lot# unknown, quantity 2); 8.0mm titanium side opening screw (part# 498.87x (length of screw is unknown), lot # unknown, quantity 1).This report is for one (1) unknown rod.This is report 2 of 2 for (b)(4).

• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• 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: 6283876
• MDR Text Key: 65999621
• Report Number: 2520274-2017-10310
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/10/2017

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?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 01/27/2017
• 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: PART# 498.003, LOT# UNKNOWN, QUANTITY 2; PART# 498.010, LOT# UNKNOWN, QUANTITY 2; PART# 498.87X, LOT # UNKNOWN, QUANTITY 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 102