MAUDE Adverse Event Report: SYNTHES MEZZOVICO SYNEX(TM) W/SM ENDPLATE/OPEN -5 DEG/23MM-31MM HEIGHT (TI); SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number	04.807.123
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Date of Event	01/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: the subject device has been received and is currently in the evaluation process.A device history record review was performed for the complaint device lot.Manufacturing location: (b)(4).Manufacturing date: dec 12, 2013.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the complaint device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on the morning of (b)(6) 2017, a patient underwent a t7 corpectomy with t5-t9 posterior spinal fusion and fixation.Expedium titanium (ti) pedicle screws were placed bilaterally at t5, t6, t8 & t9.Two (2) 5.5mm ti rods were placed using ti expedium set screws and sfx connector was placed over the t7 corpectomy space (over the cage).While the patient was recovering post-operatively, it was reported that she could not move her lower extremities and that a computerized tomography (ct) scan showed that a t5 pedicle screw was on the medial border of the pedicle and possibly touching the spinal cord.She was returned to surgery that same day.The surgeon repositioned the screw in the pedicle under routine fluoroscopy.He found the synex cage (04.807.123) was not expanded correctly.He tried to reposition it.The original void in the first surgery, earlier that day was 28mm.This cage was chosen because it was less than the void and expanded beyond the non-distracted void height.However, although the cage would expand it would not lock into place.The rod was removed on the patient¿s right side and the set screws were loosened on the patients left side.He removed the cage and replaced the cage with a smaller height range synex cage (04.807.120).The cage positioned easily, fully expanded and locked.No other patient harm or surgical time delay reported.The patient status was not reported.This complaint addresses the revision surgery, and related complaint, (b)(4), will address the adverse event of unable to move lower extremities and the right t5 pedicle screw was on medial border of the pedicle and possibly touching the spinal cord, postoperatively.Concomitant devices reported: expedium ti rods (part # unknown, lot # unknown, quantity unknown), expedium set screws (part # unknown, lot # unknown quantity one (1)), unknown rod (part # unknown, lot # unknown, quantity unknown), sfx connector.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
(b)(6).Manufacturing evaluation has been completed.As received condition of the device: parts not received in the original packaging.The components of the returned part involved in the expansion of the implant ("innenteil" component and "ring" component) were reinspected for all the features pertinent to the complaint condition.A functional test has been performed with the outcomes that the implant can expand correctly.Several post production damages have been observed on the "innenteil" component, no visual defects manufacturing related identified.Considering that all relevant measurable product features meet specification and no visual defects manufacturing related have been identified on returned item, the conclusion of the product investigation is that the returned part is conforming from a manufacturing perspective.No manufacturing related issue was identified.Product development investigation was completed.As part of this investigation a visual inspection, drawing review and device history records review were performed.The returned synex cage (04.807.123, 8775621) is an expandable vertebral body replacement device which is part of the synex system.The cage is self-locking and provides an efficient means of restoring proper spine alignment, along with rapid in situ expansion with minimal instrumentation.The cage was received with superficial damage indicative of explanation.The returned cage was sent for further investigation, and after functional testing the complaint condition was not replicated, so it was determined that the complaint condition was unconfirmed.The returned synex cage (04.807.123, 8775621) was manufactured on dec 12, 2013 and drawing was reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.During the investigation no unidentified product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the findings of manufacturing evaluation, the returned cage and its components passed dimensional and functional testing and therefore the complaint condition is unconfirmed.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.
Additional Manufacturer Narrative
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: SYNEX(TM) W/SM ENDPLATE/OPEN -5 DEG/23MM-31MM HEIGHT (TI)
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• MDR Report Key: 6287934
• Report Number: 1000562954-2017-10005
• Device Sequence Number: 16408163
• Product Code: MQP
• UDI-Device Identifier: 10705034753027
• UDI-Public: (01)10705034753027(10)8775621
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K003836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 04.807.123
• Device Lot Number: 8775621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/10/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/30/2017
• Supplement Report FDA Received Date: 03/07/2017; 03/08/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SFX CONNECTOR, QTY 1; UNKNOWN ROD, QTY UNKNOWN; UNKNOWN, EXPEDIUM SET SCREWS, QTY 1; UNKNOWN, EXPEDIUM TI RODS, QTY UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR