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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG UNKNOWN THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MDT SOFAMOR DANEK PUERTO RICO MFG UNKNOWN THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number MSB_UNK_SCREW
Device Problem Break (1069)
Patient Problems Pain (1994); Paralysis (1997); Ambulation Difficulties (2544)
Event Type  Injury  
Manufacturer Narrative
Outcomes attributed to adverse event: paralysis. Brand name: product identifiers are unknown hence brand name is unknown. Model #: product identifiers are unknown. Patient address is unknown. Date received by mfr: product identifiers are unknown hence 510k# is unknown. The device was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. 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 the patient (via a social media post) via the manufacturer representative regarding an event which occurred post a spinal fusion procedure. It was reported that the patient had a surgery in 2018 using medtronic screws. Several months later the screws broke in her back because of the alleged quality of the screws and the patient had to undergo a revision surgery to explant them. Patient had pain ambulation difficulties and paralysis for months.
 
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Brand NameUNKNOWN
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 Key15202437
MDR Text Key297683367
Report Number1030489-2022-00744
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/09/2022
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 NumberMSB_UNK_SCREW
Device Catalogue NumberMSB_UNK_SCREW
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/14/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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