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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG UNKNOWN

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MDT SOFAMOR DANEK PUERTO RICO MFG UNKNOWN Back to Search Results
Model Number MSB_UNK_SCREW
Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/25/2020
Event Type  Injury  
Manufacturer Narrative
Pma / 510k # is unknown since product identifier details are unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional via the manufacturer representative of an event occurred during an posterior arthrodesis with pelvis fixation (levels implanted: t3-s1) in the pediatric surgery block in a patient diagnosed with neurologic scoliosis. It was reported that patient had an x-ray after the original procedure and found that the second screw (which was implanted) has also been disconnected due to threading issue and the patient underwent a revision surgery in october. The product in question has had contact with the patient. The screw was placed but was removed following the issue with the threading. No patient complications reported.
 
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Brand NameUNKNOWN
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer (Section G)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer Contact
tricha miles
1800 pyramid place
memphis, TN 38132
7635140379
MDR Report Key10990438
MDR Text Key220890370
Report Number1030489-2020-01776
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMSB_UNK_SCREW
Device Catalogue NumberMSB_UNK_SCREW
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/11/2020 Patient Sequence Number: 1
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