MAUDE Adverse Event Report: SYNTHES (USA) TI LOCKING SCREW; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 04.614.508

Device Problems Migration or Expulsion of Device (1395); Unintended Movement (3026)

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

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional device product code is kwp.(b)(4).The subject device is not expected to be returned to the synthes manufacturer for evaluation and was reportedly discarded by the reporting hospital.(b)(6).(b)(4).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

Device report from (b)(6) reported the following event: it was reported that a patient underwent revision surgery including hardware removal and irrigation and debridement (i&d) of a posterior cervical construct due to post-surgical screw back-out.The original posterior cervical decompression and stabilization procedure was performed on (b)(6) 2016, between levels c2-c6 using synthes synapse cervical system implants.The construct consisted of two (2) rods and ten (10) locking screws.On an unknown date it was discovered that five (5) of the ten (10) locking screws had backed out and the rods were exposed between the locking screws.Revision surgery was performed on (b)(6) 2016.During this surgery the five (5) complaint screws were removed intact and were replaced with five (5) new synthes titanium locking screws of the same part number.The surgeon used a torque limiting handle instrument for final tightening.There was no surgical time delay or additional medical intervention required.The surgery was successfully completed with no patient harm.This report is 3 of 5 for (b)(4).

Manufacturer Narrative

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 construct consisted of two (2) rods, ten (10) polyaxial screws, and ten (10) locking caps.On an unknown date it was discovered that five (5) of the ten (10) locking caps backed out and the rods were exposed between the locking caps.Concomitant devices reported: synapse rods (part# unknown, lot# unknown, quantity# 2); polyaxial screws (part# unknown, lot# unknown, quantity# 10), locking caps (part# unknown, lot# - unknown, quantity# 5).

• Brand Name: TI LOCKING SCREW
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5973078
• MDR Text Key: 55463629
• Report Number: 2520274-2016-14659
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.614.508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2016
• 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: FIVE, UNKNOWN LOCKING SCREWS; TWO, UNKNOWN SYNTHES SYNAPSE RODS
• Patient Outcome(s): Required Intervention