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

Catalog Number 04.614.508

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Information unknown.Date of event is unknown.Additional code: kwp.Part# 04.614.508 lot# h106663.Release to warehouse date: july 20, 2016 supplier: (b)(4).No nonconformances were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Subject device has been received and is currently in the evaluation process.Product name: 3.5mmx12mm ti cancellous polyaxial screws (part# 04.614.012, lot# unknown, qty 6).Product name: 4.5mmx26mm ti cancellous polyaxial screws (part# 04.614.226, lot# unknown, qty 2).Product name: 4.5mmx28mm ti cancellous polyaxial screws (part# 04.614.228, lot# unknown, qty 2).Product name: 2nm torque limiting handle (part# 03.614.035, lot# 6458941-14, qty 1).Product name: 2nm torque limiting handle (part# 03.614.035, lot# 83870-097, qty 1).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 patient underwent revision surgery due to hardware migration.Patient had an anterior corpectomy at unknown level and posterior fusion with synapse at c4-c6 and t1-t2 on (b)(6) 2016 due to spinal stenosis.Patient was implanted with an unknown plate anteriorly.The following were implanted posteriorly: two 3.5mmx240mm titanium (ti) rods, six 3.5mmx12mm ti cancellous polyaxial screws at c4-c6, two 4.5mmx26mm ti cancellous polyaxial screws at t1, two 4.5mmx28mm ti cancellous polyaxial screws at t2, and ten ti locking screws.X-rays taken during the six weeks follow up on unknown date confirmed that the two locking screws at t2 came out of the screws and were floating freely.The two rods at t2 were out of the screws.It is unknown if patient reported any adverse events.Surgeon was concerned and indicated that the migration could be caused by two scenarios: either the rods were not long enough or the two 2nm torque limiting handles used in the initial surgery may not have tightened the locking screws all the way.There were no reported issues with the handles during the initial surgery.A revision surgery was performed on (b)(6) 2017.Surgeon removed and replaced all locking screws.Surgeon added a longer rod due to preference.All devices were removed intact and there were no damages observed.Revision surgery was successfully completed without requiring medical intervention.No surgical delays reported.Patient status/outcome was reported as stable.Concomitant devices reported: plate (part# unknown, lot# unknown, qty 1), 3.5mmx12mm ti cancellous polyaxial screws (part# 04.614.012, lot# unknown, qty 6), 4.5mmx26mm ti cancellous polyaxial screws (part# 04.614.226, lot# unknown, qty 2), 4.5mmx28mm ti cancellous polyaxial screws (part# 04.614.228, lot# unknown, qty 2), ti locking screws (part# 04.614.508, lot# unknown, qty 8), 2nm torque limiting handle (part# 03.614.035, lot# 6458941-14, qty 1), 2nm torque limiting handle (part# 03.614.035, lot# 83870-097, qty 1).This is report 1 of 4 for (b)(4).

Manufacturer Narrative

Additional product codes: mnh, mni.A product investigation was completed: the returned devices were evaluated at customer quality and the complaint condition could not be replicated or confirmed as the reported events occurred in situ.The returned locking screws (04.614.508 lots h106663 and 9981185 were in fairly good condition considering implantation and explantation.The recess and threads each showed minimal wear.The root cause of the complaint cannot be determined.The rods (part 498.957, lots 5513074 and 6280827 were returned with post manufacturing cuts on one end, bent (likely due to surgeon¿s preference) and scratched in multiple locations from what appears to be pliers.The rod is held in place through the interaction between the 3-d head and the locking screw.Displacement can only occur if the locking cap had loosened as such the root cause of the displacement is isolated to the loosening of the locking screw.It was suspected that the two (2) torque handles (part 03.614.035, lots 83870-097 and 6458941-14) did not torque the locking caps as intended during the initial surgery.The parts were also returned but the intraoperative complaint will be investigated under linked complaint (b)(4).Two (2) outer sleeves for the 03.632.036 matrix holding sleeve were returned as a concomitant device without an alleged complaint condition.Upon visual inspection there is no evidence that this device contributed to the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, device history record (dhr) review, risk assessment review, complaint history review, and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint cannot be confirmed as x-rays were not provided.No new malfunctions were identified during the investigation.Per the technique guide, the 04.614.508 locking screws are utilized in the synapse oct system for posterior stabilization of the upper spine.A t15 stardrive screwdriver shaft is utilized to insert/final tighten the locking screws.Relevant product drawings were reviewed.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.Review of the device history records showed that there were no issues during the manufacture of the products that would contribute to the complaint conditions.The design is adequate for its intended use when used and maintained as recommended, it did not contribute to the complaint condition.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.

• Brand Name: TI LOCKING SCREW
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6376985
• MDR Text Key: 69045791
• Report Number: 1719045-2017-10177
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10705034739229
• UDI-Public: (01)10705034739229(10)H106663
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.614.508
• Device Lot Number: H106663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: (PART# 03.614.035, LOT# 6458941-14, QTY 1); (PART# 03.614.035, LOT# 83870-097, QTY 1); (PART# 04.614.226, LOT# UNKNOWN, QTY 2); (PART# 04.614.228, LOT# UNKNOWN, QTY 2); 1 QTY FOR UNKNOWN PLATE; PART# 04.614.012, LOT# UNKNOWN, QTY 6); TI LOCKING SCREWS(PART# 04.614.508,LOT# UNK, QTY8)
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR