UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2020-02-05 for UNK manufactured by Medtronic Sofamor Danek Usa, Inc..

Event Text Entries

[187390154] Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[187390155] Total patients involved: 14 patients (08 male and 06 female) underwent revision surgery after bkp and 105 (21 male and 84 female) consecutive patients underwent single bkp, age: 79. 7 years (mean age). It was reported via literature titled " characteristic radiological findings for revision surgery after balloon kyphoplasty" post-op, a total of 120 patients in which 14 patients underwent revision surgery after balloon kyphoplasty (bkp). Radiographs revealed cement dislodgement to the anterior and a fracture of the caudal vertebral body (l2). Revision surgery was performed for uncontrolled back pain or neurological deficit after bkp, due to cement dislodgement, recollapse of the vertebra, and adjacent vertebral fracture. An l1 corpectomy was performed, with autografting and posterior fixation from t10 to l3. The clinical reasons for revision surgery included back pain in 13 patients and leg pain in 1 patient. Posterior fusion was performed in 10 patients. Anterior and posterior fusion were performed in 4 patients for cement dislodgement repair. During posterior fusion, posterior instrumentation and bone grafting were performed, without cement removal. In anterior and posterior fusion, cement removal and bone grafting were performed, using an anterior approach, and posterior instrumentation was added. Adverse events: pedicle fracture of the caudal vertebral body (l2), and posterior wall injury, split type fracture, back pain, leg pain.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1030489-2020-00144
MDR Report Key9669884
Report SourceFOREIGN,LITERATURE
Date Received2020-02-05
Date of Report2020-02-05
Date Mfgr Received2020-01-11
Date Added to Maude2020-02-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTACIE ZIEMBA
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 38132
Manufacturer CountryUS
Manufacturer Postal38132
Manufacturer Phone9013963133
Manufacturer G1MEDTRONIC SOFAMOR DANEK USA, INC.
Manufacturer Street1800 PYRAMID PLACE
Manufacturer CityMEMPHIS TN 85281
Manufacturer CountryUS
Manufacturer Postal Code85281
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameCEMENT, BONE, VERTEBROPLASTY
Product CodeNDN
Date Received2020-02-05
Model NumberNA
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC SOFAMOR DANEK USA, INC.
Manufacturer Address1800 PYRAMID PLACE MEMPHIS TN 85281 US 85281


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-05

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