MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: SYNAPSE; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number UNK - CONSTRUCTS: SYNAPSE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 08/16/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk constructs: synapse/ part and lot numbers are unknown; udi number is unknown.Without the specific part number the device history records review could not be completed; and the udi number is unknown.Complainant device is not expected to be returned for manufacturer review/ investigation.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.The investigation could not be completed; no conclusion could be drawn, as no product was received.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

This report is being filed after the review of the following journal article: park hh, et al (2020), the timing of fusion surgery for clival chordoma with occipito-cervical joint instability: before or after tumor resection? neurosurgical review, volume 43, page 119-129, (south korea).The purpose of this study is to determine the significance of the timing of occipito-cervical (oc) fusion in clival chordoma with oc joint instability.The authors investigate and compare the clinical outcome related to oc joint instability, fusion, and surgery time between one-stage oc fusion after tumor resection and two-stage oc fusion before tumor resection.From december 2008 to september 2014, 22 patients underwent surgery for clival chordoma.Of the 22 patients, 8 underwent oc fusion due to tumor invasion and instability of the oc joint and were included in the study.There were 4 male and 4 female patients with a mean age of 34.9 years (range, 17¿51 years).4 patients underwent oc fusion before tumor resection and the other 4 patients underwent oc fusion after tumor resection.Oc fusion was performed using a rigid plate and poly-axial screw-rod system with either an unknown depuy spine summit si oct spinal fixation system or an unknown synthes synapse oct system.All patients were put on a firm and rigid cervical collar after oc fusion for 1 month, regardless of the sequence of oc fusion.Plain x-ray films of the cervical spine including flexion-extension were evaluated every month to assess fusion status.Imaging studies for oc fusion and tumor resection were performed within 1 month, annually for the first 2 years, and every 2 to 3 years thereafter.The mean follow-up duration was 3.8 years (range, 0.1¿7.7 years).The authors did not specify which patients were implanted with the synthes device.Thus, complications will be reported as follows: patient 1 had tumor surgery site infection and central nervous system infection due to prolonged surgery time.Patient 2 had pneumonia and central nervous system infection due to prolonged surgery time.Patient 3 had tumor surgery site dehiscence.The patient had undergone tumor resection 9 years earlier using a far-lateral approach.The tumor was near completely resected by a combined transoral and transfacial approach (weber ferguson approach) with a temporalis muscle flap to cover the dural defect.Tumor resection was uncomplicated, but dehiscence occurred at the transoral surgery site after oc fusion.The defect was repaired immediately, but a central nervous system infection followed.Consequently, the patient died a few weeks later from uncontrolled encephalitis.Patient 4 had delayed fixation surgery due to a cardiac arrest during patient positioning for fixation.Fortunately, the patient recovered with no other neurological deficits and went on to receive fixation surgery a few days later.Patient had postoperative central nervous system infection due to prolonged surgery time.This impacted product captures patient 3 who had tumor surgery site dehiscence that was repaired immediately but cns infection followed and patient died due to uncontrolled encephalitis.This report is for the unknown synthes synapse oct system.Orthosis, cervical pedicle screw spinal fixation.This report is for one (1) unk - constructs: synapse.This report is 3 of 4 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: SYNAPSE
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA
• MDR Report Key: 11850034
• MDR Text Key: 263851280
• Report Number: 8030965-2021-04028
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - CONSTRUCTS: SYNAPSE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention