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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SPINE CLAMP FOR SPINE NAVIGATION PACKAGE NEUROLOGICAL STEREOTAXIC INSTRUMENT

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STRYKER INSTRUMENTS-KALAMAZOO SPINE CLAMP FOR SPINE NAVIGATION PACKAGE NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6002-016-000
Device Problem Imprecision (1307)
Patient Problem Peroneal Nerve Palsy (2362)
Event Date 05/13/2013
Event Type  Injury  
Event Description
It was reported that during a spinal procedure utilizing a stryker navigation system, stryker spine clamp, stryker spinemap software, stryker xia cannulated probe, stryker es2 spinal system and a siemens orbic c-arm the spine clamp was thought to have been bumped, causing the system and software to become inaccurate, resulting in the inaccurate placement of 4 screws. At the completion of the procedure, a spin was taken with the siemens orbic c-arm, at which time the screws were identified to have been inaccurately placed. The surgeon removed the screws and closed. It was further reported that a revision surgery was completed approximately one week later to place the screws and was completed successfully. It was further reported that the patient was experiencing foot drop, but no further information regarding the patient¿s outcome was provided.
 
Manufacturer Narrative
The device was not returned for evaluation.
 
Event Description
It was reported that during a spinal procedure utilizing a stryker navigation system, stryker spine clamp, stryker spinemap software, stryker xia cannulated probe, stryker es2 spinal system and a siemens orbic c-arm the spine clamp was thought to have been bumped, causing the system and software to become inaccurate, resulting in the inaccurate placement of 4 screws. At the completion of the procedure, a spin was taken with the siemens orbic c-arm, at which time the screws were identified to have been inaccurately placed. The surgeon removed the screws and closed. It was further reported that a revision surgery was completed approximately one week later to place the screws and was completed successfully. It was further reported that the patient was experiencing foot drop, but no further information regarding the patient¿s outcome was provided.
 
Event Description
It was reported that during a spinal procedure utilizing a stryker navigation system, stryker spine clamp, stryker spinemap software, stryker xia cannulated probe, stryker es2 spinal system and a siemens orbic c-arm the spine clamp was thought to have been bumped, causing the system and software to become inaccurate, resulting in the inaccurate placement of 4 screws. At the completion of the procedure, a spin was taken with the siemens orbic c-arm, at which time the screws were identified to have been inaccurately placed. The surgeon removed the screws and closed. It was further reported that a revision surgery was completed approximately one week later to place the screws and was completed successfully. It was further reported that the patient was experiencing foot drop, but no further information regarding the patient¿s outcome was provided.
 
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Brand NameSPINE CLAMP FOR SPINE NAVIGATION PACKAGE
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key6211498
MDR Text Key63470382
Report Number0001811755-2016-02920
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K012380
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number6002-016-000
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/28/2016 Patient Sequence Number: 1
Treatment
ES2 SPINE SYSTEM (MIES2ST13031SSP, SN: UNK); SIEMENS ORBIC C-ARM (UNK CATALOG & SN); SPINEMAP 3D 2.0 SOFTWARE (6002-660-000, SN:UNK); STRYKER NAVIGATION SYSTEM (6000115000, SN: UNK); XIA CANNULATED PROBE (42105002SSP, SN: UNK)
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