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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GLOBUS MEDICAL, INC. CREO PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

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GLOBUS MEDICAL, INC. CREO PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS Back to Search Results
Model Number 1134.0100
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)
Event Date 08/16/2019
Event Type  Malfunction  
Event Description

Patient returned to the operating room 72 hours status post l4-l5, l5-s1 transforaminal lumbar interbody fusion. Imaging indicated that the left s1 screw tulip had broken off. Lumbar spine hardware revision with removal and replacement of left s1 pedicle screw.

 
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Brand NameCREO
Type of DevicePEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
Manufacturer (Section D)
GLOBUS MEDICAL, INC.
2560 general armistead ave
valley forge business center
audubon PA 19403
MDR Report Key9069584
MDR Text Key158629145
Report Number9069584
Device Sequence Number1
Product Code OSH
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 08/30/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/16/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number1134.0100
Device Catalogue Number1134.0100
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/30/2019
Event Location Hospital
Date Report TO Manufacturer09/16/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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