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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC CONN O/C ANGLD 5.5-6.35X5.5TI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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DEPUY SPINE INC CONN O/C ANGLD 5.5-6.35X5.5TI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 179774555
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Foreign Body Reaction (1868); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Event date: (b)(6) 2019, 4 pm. Event description: broken rods and metallosis. Date j&j became aware: (b)(6) 2019, 4 pm. Name of reporter: (b)(6). Hospital name: (b)(6). Hospital town: (b)(6). Product: cocr 5. 5 mm rod, di expedium screws, unitised set screws, connector. Lot/batch/exp: unknown. Product number: 179774555, 179722050, 179722644, 198769480. Did the event happen during a procedure? no. Were you in the procedure at the time of the event? yes. Was the product being used in a clinical trial? no. Event outcome/how was it managed? rods replaced, blood was not used when sediment discovered. Was there a patient impact or was the procedure due to the failure? patient has metallosis. Has the reporter facility indicated there may be legal action? no. Is the product available for return? hopefully if returned from sterilisation successfully. Please give a detailed explanation of the event: the patient was undergoing revision surgery in which the cocr rods had snapped on both the left and the right side. The surgeon removed set screws, rods connectors and screws. Upon removal of the metal work, there was considerable metallosis on the patient¿s tissue. The anesthetist was using cell salvage to give back the patient, their own blood. Upon spinning down and giving back the blood to the patient, dr (b)(6) (the anesthetist) noticed, metallic, lumpy, greasy components in the patient¿s blood. It is thought this is from the metallosis. Blood samples have been sent for biochemical analysis in (b)(6). Surgeon name; mr (b)(6). This complaint involves five (5) devices.

 
Manufacturer Narrative

(b)(4).

 
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Brand NameCONN O/C ANGLD 5.5-6.35X5.5TI
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
MEDOS INT SPINE
chemin blanc 38
le locle
SZ
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9139944
MDR Text Key167185166
Report Number1526439-2019-52173
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK142460
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/10/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number179774555
Device Catalogue Number179774555
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 Received09/10/2019
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? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 10/01/2019 Patient Sequence Number: 1
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