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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® FENESTRATED SCREW SET THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MDT SOFAMOR DANEK PUERTO RICO MFG CD HORIZON® FENESTRATED SCREW SET THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 55851025545
Device Problems Break (1069); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2022
Event Type  Injury  
Manufacturer Narrative
Outcomes attributed to adverse event: revision surgery is scheduled. The following screws were reported: product #55851025545, lot# unknown, quantity: 2 product #55851025550, lot# unknown, quantity: 2 it is unknown which two screws from the reported screws were broken. Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿. These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting. Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional via manufacturer representative regarding a patient having percutaneous trauma stabilization for t12 burst fracture. Levels implanted: t11-l1 it was reported that the screws shanks broke under tulip. 1-month post-operative, the surgeon reported that 1 screw had broken, at 3 months follow up 2 screws had broken. Removal of screws and fusion is scheduled to happen in the next 2 weeks due to broken screws and loss of correction. Patient symptoms are unknown. No further complications were reported regarding the event. Additional information was received that only 2 screws broke and it is unknown which screws broke.
 
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Brand NameCD HORIZON® FENESTRATED SCREW SET
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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
glen belmer
1800 pyramid place
memphis, TN 38132
6122713209
MDR Report Key15202385
MDR Text Key297680788
Report Number1030489-2022-00749
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00763000143756
UDI-Public00763000143756
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K201362
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number55851025545
Device Catalogue Number55851025545
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/10/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/10/2022 Patient Sequence Number: 1
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