MAUDE Adverse Event Report: SYNTHES GMBH UNK - RODS; ROD, FIXATION, INTRAMEDULLARY

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - rods: spine/unknown lot.Part and lot numbers are unknown; udi number is unknown.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that, on an unknown date the patient suffered from jefferson fracture, and the halo vest was put on him.On (b)(6) 2021 the primary pcf (o-c4) treating was performed.The symphony oct was applied without surgical delay.On (b)(6) it was reported that the patient had suffered from dysphagia.On (b)(6) the patient is scheduled to undergo a revision procedure.The surgeon commented as follows: severity of the adverse effect is ¿mild to moderate¿ as he thinks that re-reduction in the upcoming revision procedure will correct the event.It was preoperatively confirmed that the banion made contact with the odontoid process.On the other hand, the odontoid process has positioned forward postoperatively.This shift has put pressure on the pharynx.The atlas (c1) has largely shifted, and the joint(s) between o-c has been disjointed to a large extent.The event might have been triggered by rod deployment during the primary procedure.He was not able to deploy the rod at an appropriate angle.So rod re-deployment is under consideration in the upcoming revision procedure.Another possible cause, if any, for the event is this.They temporarily detached the halo vest when they changed the patient¿s posture during the primary procedure.While the halo vest was being detached, the reduction angle and/or position happened to be shifted.This report is for one (1) unk - rods.This is report 1 of 2 for complaint (b)(4).

• Brand Name: UNK - RODS
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 12294994
• MDR Text Key: 265623356
• Report Number: 8030965-2021-06522
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 79 YR