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

Model Number MSB_UNK_SCREW

Device Problems Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Chao li., hao li., junxiao su., zheng wang., donglai li., yonghao tian., suomao yuan., lianlei wang., xinyu liu., ¿comparison of the accuracy of pedicle screw placement using a fluoroscopy-assisted free-hand technique with robotic-assisted navigation using an o-arm or 3d c-arm in scoliosis surgery¿.Global spine journal.2022, vol.0(0) 1¿10.Doi: 10.1177/21925682221143076 date of event: no published or accepted date provided in the literature.Brand name is unknown.Product identifiers are unknown.Date rec'd by mfr: 510(k)# is unknown.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.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

Chao li., hao li., junxiao su., zheng wang., donglai li., yonghao tian., suomao yuan., lianlei wang., xinyu liu., ¿comparison of the accuracy of pedicle screw placement using a fluoroscopy-assisted free-hand technique with robotic-assisted navigation using an o-arm or 3d c-arm in scoliosis surgery¿.Global spine journal.2022, vol.0(0) 1¿10.Doi: 10.1177/21925682221143076 objectives: to report and compare the application of robotic-assisted navigation with an o-arm or three dimensional (3d) c-arm-assisted pedicle screw insertion in scoliosis surgery, and compare with free-hand technique.Methods: one hundred and forty-four scoliosis patients were included in this study.Ninety-two patients underwent roboticassisted pedicle screw insertion (group a), and 52 patients underwent freehand fluoroscopy guided pedicle screw insertion (group b).Group a was further divided into subgroup ai (n = 48; robotic-assisted navigation with an o-arm) and subgroup aii (n = 44; robotic-assisted navigation with a 3d c-arm).The evaluated clinical outcomes were operation time, blood loss, radiation exposure, postoperative hospital stay, and postoperative complications.The clinical outcomes, coronal and sagittal scoliosis parameters and the accuracy of the pedicle screw placement were assessed.Conclusions: robotic-assisted navigation with an o-arm or 3d c-arm effectively increased the accuracy and safety in scoliosis surgery.Compared with robotic-assisted navigation with a 3d c-arm, robotic-assisted navigation with an o-arm was more efficient intraoper atively.One hundred and forty-four scoliosis patients were included in this study and were divided into 2 groups.Ninety-two patients with an average age of 32.2 years (range 9-66 years) underwent robot-assisted pedicle screw insertion (group a), namely 18 cases of congenital scoliosis, 8 cases of neuromuscular scoliosis, 30 cases of idiopathic scoliosis, and 36 cases of degenerative scoliosis.Fifty-two patients with an average age of 29.1 years (range 8-69 years) were treated with a fluoroscopy-assisted free-hand technique (group b), namely 12 cases of congenital scoliosis, 5 cases of neuromuscular scoliosis, 19 cases of idiopathic scoliosis, and 16 cases of degenerative scoliosis.Group a was further divided into subgroup ai (48 patients who underwent robotic-assisted navigation using an o-arm) and subgroup aii (44 patients who underwent robotic-assisted navigation using a 3d c-arm).Reportable event: in subgroup ai, the postoperative infection was occurred in 1 patient.Dural tear was occurred in 1 patient in group aii.Dural tear and neurological deficits related to the misplacement pedicle screw occurred after surgery in 1 and 2 patients, respectively, in group b; moreover, 1 of the patients with neurological deficits needed reoperation.

Manufacturer Narrative

H6: the device code (fdd/annex a) has been corrected 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.

• Brand Name: UNKNOWN
• Type of Device: THORACOLUMBOSACRAL 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 Key: 16442210
• MDR Text Key: 310227829
• Report Number: 1030489-2023-00117
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_SCREW
• Device Catalogue Number: MSB_UNK_SCREW
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 02/27/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other