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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - LOCKING/SET SCREWS: SYNAPSE ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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SYNTHES GMBH UNK - LOCKING/SET SCREWS: SYNAPSE ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number UNK - LOCKING/SET SCREWS: SYNA
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

This report is for an unknown screw/unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. 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. (b)(4). 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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2019 the patient underwent a cervical vertebrae fusion from the 3rd to 5th cervical vertebrae due to a fracture of the 5th vertebrae. On (b)(6) 2020 the patient complained about head aches, pain in the shoulder while eating, and pain on the right side. The patient was also unable to feel cold and warm. On (b)(6) 2020 it was noted that the right rod had moved completely into the brain. The left rod had also moved towards brain but still remained in the c3 and c4 screw head. A revision operation was performed on (b)(6) 2020. The skull was opened to remove the right rod from the brain. The left rod was also removed. To remove the left rod a screw driver had to be used. A normal amount of force was used to loosen the screw and nut which weren't loose. The skull was closed with a small plate and cement. A new rod was placed into the existing screws which were tightened with nuts. The revision surgery was completed successfully. The head and shoulder pain has become less. This report is for one (1) unknown screw. This is report 8 of 8 for (b)(4). This report is linked to (b)(4).

 
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Brand NameUNK - LOCKING/SET SCREWS: SYNAPSE
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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 Key10560508
MDR Text Key207755651
Report Number8030965-2020-07257
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/21/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK - LOCKING/SET SCREWS: SYNA
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 Received12/10/2020
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?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 09/21/2020 Patient Sequence Number: 1
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