MAUDE Adverse Event Report: SYNTHES USA; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Failure of Implant (1924); Impaired Healing (2378); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional patient id reported (b)(4).This report is for one (1) unknown screw.Part#, lot# and udi # is not available.Device was implanted in (b)(6) 2016.Exact date is unknown.Device was not explanted.Device fragment remained in patient.Device is not expected to be returned for manufacturer review/investigation.Therapy date of each of the concomitant devices is unknown.This report is for one (1) unknown screw.Pma/510(k) number is not available.(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 the surgeon performed a c1-t3 posterior cervical fusion on the patient in (b)(6) 2016 using synapse 3.5mm rod system including the following, (2) synapse 3.5mm shaft screws ¿ unknown length, (14) synapse screws ¿ unknown sizes, (16) synapse locking caps, and (2) 3.5 x 240mm rods.At an unknown point in time, the patient did not heal and has a nonunion.The left c1 synapse 3.5mm shaft screw (unknown length, and part and lot information is scratched ¿ cannot be read) broke at an unknown point in time.The surgeon also remarked that the c2 screws appear to be loosening in the bone and have lucencies on the ct scan.On (b)(6) 2016, the surgeon performed the revision.The surgeon then removed all the synapse hardware from the (b)(6) 2016 surgery.He could not get out the distal part of the left c1 screw that was broken.The surgeon replaced all the hardware with new synthes synapse 4.0mm rod system hardware.He did not replace the screws at c1 and c2.He did extend the construct up to the occiput with the synthes oc fusion set.He also used the synthes spine cable system to place c2 sublaminar wires that he ran to the rods.The surgeon then connected and tightened all the hardware and successfully completed the procedure.Patient outcome was reported as unknown.Concomitant parts reported: right-c1 synapse 3.5mm shaft screw, (part# unknown, lot# unknown, quantity 1).C3 synapse screws (part# unknown, lot# unknown, quantity 12).Synapse locking caps (part# 04.614.508, lot # unknown, quantity 16).:3.5mm ti rods-240mm (part# 498-957, lot# unknown, quantity 2).This report is for one (1) unknown screw.This is report 1 of 3 for com-(b)(4).

• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• 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: 6233617
• MDR Text Key: 64189465
• Report Number: 2520274-2017-10085
• Device Sequence Number: 1
• Product Code: NKG
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2017
• 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?: Yes
• Date Manufacturer Received: 12/16/2016
• 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: ONE (1) UNKNOWN SHAFT SCREW; PART# 04.614.508, LOT # UNKNOWN, QUANTITY 16; PART# 498.957, LOT# UNKNOWN, QUANTITY 2; TWELVE (12) UNKNOWN SYNAPSE SCREWS
• Patient Outcome(s): Required Intervention