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

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(6).Patient weight is not available for reporting.This report is for one (1) unknown ti rod.Part#, lot# and udi # is not available.Potential part # 498.29x.Implant procedure was done in 2009.Exact date is unknown.Device is not expected to be returned for manufacturer review/investigation.Therapy date of concomitant devices is unknown.This report is for one (1) unknown ti rod.Pma/510(k) number is not available.Potential 510(k) # is k082572.(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 a revisions surgery was performed on (b)(6) 2016 for a broken right rod above the s1 screw.The patient has hardware from the occiput to the s1; synthes oc fusion in the occiput / synthes synapse in cervical spine / and synthes uss in the thoracolumbar region caudal to s1.The patient reported as having lumbar back pain and it was determined that the patient had a broken rod.The surgeon removed the s1 screws and then cut the rods in situ between l1 and l2.He removed the caudal part of the rods that were cut.Surgeon placed new synthes uss screws at l3, l4, l5, and replaced the s1 screws.He then placed 2 parallel rod connectors on the left and right rods that were still implanted in the patient.He then contoured 2 new 6.0 mm tan rods (unknown size).He connected the new rods to the existing rods in the patient with the parallel connectors.He then connected the rods to the lumbosacral screws.He then placed iliac screws and connected them to the rods.The new hardware he placed was synthes uss.Procedure was completed successfully.No surgical delay was reported.Concomitant devices reported: screws (part # 498.Xxx, quantity 2).Ti collar with grooves (part# 498.011, quantity 2).Ti nut 11 mm width across flats (part# 498.003, quantity 2).This report is for one (1) unknown ti rod.This is report 1 of 1 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: 6215505
• MDR Text Key: 63631386
• Report Number: 2520274-2016-15808
• 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: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• 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
• Date Manufacturer Received: 12/05/2016
• 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
• Treatment: PART# 498.003, LOT# UNKNOWN, QUANTITY 2; PART# 498.011, LOT# UNKNOWN, QUANTITY 2; TWO (2) UNKNOWN SCREWS
• Patient Outcome(s): Required Intervention