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

Catalog Number 04.614.508

Device Problem Unintended Movement (3026)

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

Event Type  Injury  

Manufacturer Narrative

Additional device product codes are nkg, kwp, mnh.(b)(4).Therapy date: unknown date in (b)(6) 2016.The subject device is not expected to be returned to the synthes manufacturer for evaluation as it is still implanted in the patient.(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.One unknown synapse screw; based on the complaint description and system used part number is most likely: 04.614.508 (locking screw synapse, titanium alloy).Please note that no product was returned and the investigation will be based on the x-rays provided for this complaint.A visual inspection (x-ray) was performed as part of this investigation.This complaint is confirmed.The 04.614.508 locking screws are utilized in the synapse oct system for posterior stabilization of the upper spine per relevant technique guide.A t15 stardrive screwdriver shaft is utilized to insert/final tighten the locking screws.The system technique guide states the follow regarding inserting locking caps: ¿ after final adjustment of the construct, fully tighten all locking screws with the screwdriver shaft and the 2 nm torque limiting handle.The construct is now rigidly locked.Final tightening should be accomplished after all locking screws have been placed, and should be aided by the countertorque tool.¿ upon reviewing the x-rays provided in the complaint, one screw has indeed migrated from the rod resulting in the complaint description.Replication of the complaint condition is not applicable as no product was returned.This complaint is confirmed.A device history record (dhr) review could not be done for this complaint as the part/lot number is unknown.No definitive root cause could be determined as the circumstances surrounding the complaint are unknown.During the investigation, no product design issues or discrepancies were observed that may have contributed 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.

Event Description

It was reported that initial surgery to treat a traumatic spine fracture (flexion distraction injury) on an unknown date in (b)(6) 2016 was performed using the synthes synapse 4.0mm rod system.The construct included level c5 and c6 lateral mass screws, (skipping c7), and t1 and t2 pedicle screws ¿ all were synapse screws of unknown size.On an unknown date it was discovered by postoperative x-ray that the right c5 screw had migrated cranially and is no longer connected to the rod.The locking screw appears to still be threaded into the synapse screw head.It is unknown if the patient had any symptoms leading up to the discovery of the reported malfunction.The surgeon thought that he performed a final tightening of the hardware during the initial surgery.Currently, the surgeon does not think that the rod has slid on the caudal end of the right side construct.He also did not believe that the left rod has any issues at this time.According to the surgeon, the patient does not tolerate surgery very well so he will follow the patient closely.He thinks that the patient may go on to have fusion surgery in the future.The patient does have some coronal plane deformity now.Concomitant medical products: unknown synthes synapse 4.0mm rod, unknown part and lot numbers, quantity x 2; ti locking screws, part 04.614.508, unknown lot, quantity x 7; unknown synapse 4.0 screw (unknown size), unknown part and lot numbers, quantity x 7.This is report 2 of 2 for complaint (b)(4).

• Brand Name: TI LOCKING SCREW
• Type of Device: ORTHOSIS, PEDICEL 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: 6555760
• MDR Text Key: 74790200
• Report Number: 1719045-2017-10445
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2017

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: Health Professional
• Device Catalogue Number: 04.614.508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 05/09/2017
• 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: 04.614.508, TI LOCKING SCREWS, QTY 7; UNKNOWN SYNAPSE 4.0MM ROD, QTY 2; UNKNOWN SYNAPSE 4.0MM SCREWS, QTY 7
• Patient Outcome(s): Required Intervention