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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
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Myocardial Infarction (1969)
Event Date 02/03/2022
Event Type  Death  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, during the procedure the surgeon opened the "ocfusion" section, it was noticed that the locking nuts needed to fix the occipital plate were missing from kit. Other nuts were needed for the procedures. There was a surgical delay of twenty (20) minutes. After the surgery, upon awakening the patient had a heart attack and died. This report involves one (1) unknown locking/set screws: synapse. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
510k: this report is for an unknown locking/set 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. Reporter is a synthes employee. 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. Medical device problem code a27 used to capture device not available/missing. 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.
 
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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 Key13508319
MDR Text Key285424990
Report Number8030965-2022-00828
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2022
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? No
Date Manufacturer Received02/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/10/2022 Patient Sequence Number: 1
Treatment
UNK - PLATES: OCCIPITAL
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