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U.S. Department of Health and Human Services

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

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SYNTHES GMBH UNK - RODS ROD, FIXATION, INTRAMEDULLARY Back to Search Results
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).
 
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Brand NameUNK - RODS
Type of DeviceROD, 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 Key12294994
MDR Text Key265623356
Report Number8030965-2021-06522
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received08/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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