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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAMBER SPINE TECHNOLOGIES ORTHROS MIS; ORTHROS MIS SET SCREW
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CAMBER SPINE TECHNOLOGIES ORTHROS MIS; ORTHROS MIS SET SCREW Back to Search Results
Model Number CM-002-10
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem Malunion of Bone (4529)
Event Date 11/30/2022
Event Type  Injury  
Event Description
Intitial surgery was performed in patient on (b)(6) 2022.Post-op x-ray indicated the surgery went well with no anomolies.Later during a routine x-ray scan done on (b)(6)2022 it was found out that an orthros mis set screw was freely floating inside the patient.The posterior construct implanted on that day was bilateral from l4-s1.A revision surgery was done on (b)(6) 2022.The patient was obsese and had a sclerotic bone which made the surgery little bit challenging.
 
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Brand Name
ORTHROS MIS
Type of Device
ORTHROS MIS SET SCREW
Manufacturer (Section D)
CAMBER SPINE TECHNOLOGIES
501 allendale rd
suite 101
king of prussia PA 19406
MDR Report Key16582564
MDR Text Key311672313
Report Number3010197239-2022-00001
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180980
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberCM-002-10
Device Lot NumberBG16021C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight136 KG
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