MAUDE Adverse Event Report: SYNTHES GMBH UNK - MONO/POLYAXIAL SCREWS: SYNAPSE; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/31/2020

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown mono/polyaxial screws: synapse/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.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: chen y.Y., chao l.C., fang j.J., lee e.J., (2020)3d-customized guiding template for posterior fixation in complex atlantoaxial instability¿ preliminary experiences of national cheng kung university hospital, j neurol surg rep volume 81, pages e20¿e27, (taiwan).This study presents case reports of patients' experience during atlantoaxial fixation in complex cervical deformity with 3d-customized guiding template.The posterior atlantoaxial fixation surgery was done using the posterior fixation system synapse produced by depuy synthes company.(case 1) a case of a (b)(6) year-old woman, who has polio infection since her childhood and resulted in right limbs muscle atrophy.She came to our hospital due to neck pain with decreased four limbs muscle power.Through image studies, type 2 odontoid fracture with atlantoaxial subluxation and dens invagination were diagnosed.Severe spinal stenosis with myelopathy was identified at c1¿2 level.There was also severe kyphoscoliosis at cervical and thoracic spine.Her va had no variant despite the deformity.The operation was done smoothly.No va injury was noted during operation, and we obtained cervical ct image to validate the result.In the ct image after operation, we found her left side c2 screw breached the transverse foramen.The screws in c2 have grade 2 deviation at the left side and the trajectory of right c2 pedicle screw has a bit different from the original design.Although screw has breached through, her postoperative ct angiography showed patent left va without blood flow decrease or lumen narrowing.(case 2) a case of a (b)(6) year-old woman who came in for neck pain with limited neck motion.Cervical spine images showed c1¿2 subluxation and herniated intervertebral disc at c6¿7 level.There was mild spinal stenosis at c1¿2 level while in neutral position.In preoperative evaluation, the va had no variant, but bilateral c2 pedicles were thin, around 2.6mm.The operation was done smoothly.No va injury was noted during operation.Postoperative cervical ct showed right c2 pedicle screw breached into the left c2 transverse foramen, and the trajectory was deviated from preoperative planning.The deviation grade at c1 is 0, and 1 at both side of c2.Although breach through, bilateral va was patent on postoperative angiography.This report is for an unknown synthes synapse screw.

• Brand Name: UNK - MONO/POLYAXIAL SCREWS: SYNAPSE
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11821627
• MDR Text Key: 265171905
• Report Number: 8030965-2021-03923
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2021
• 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
• Patient Outcome(s): Required Intervention