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

Model Number MSB_UNK_SCREW

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Muscle Weakness (1967); Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id: msb_unk_screw, lot #: unknown, ubd: unknown , udi#: asku ; product id: msb_unk_screw, lot #: unknown, ubd: unknown, udi#: asku.The average age of patients is 54.3 years.This value is the average age of the patients reported in the article as specific patients could not be identified.Date of event: please note that there is no information with regard to event date as the event dates were not provided in the published literature.Product identifiers are unknown.510k# is unknown as product identifiers are not known.Alomari, s., lubelski, d., lehner, k., tang, a., wolinsky, j., theodore, n., sciubba, d.M., lo, s., belzberg, a., weingart, j., witham, t., gokalsan, z., bydon, a.Safety and accuracy of freehand pedicle screw placement and the role of intraoperative o-arm: a single institution experience.Wolters kluwer health, inc.2022.Doi:10.1097.Brs.0000000000004497.H6: 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

Summary: a single-institution retrospective chart review identified adult patients who underwent freehand pedicle screw placement in the thoracic, lumbar or sacral levels.Patients were stratified into three cohorts based on the intraoperative imaging modality used to assess the accuracy of screw position: intraoperative x-rays (cohort 1); intraoperative o-arm (cohort 2); or intraoperative ct-scan (cohort 3).Postoperative ct scans were performed on all patients in cohorts 1 and 2.Postoperative ct-scan was not required in cohort 3.When compared to intraoperative x-ray, intraoperative o-arm verification decreased the revision surgery rate for malpositioned screws.Reported events: 1.Postoperative ct-scans identified 65 and 127 malpositioned screws in cohorts 1 and 2, respectively.Of these 192 screws, 11 were significantly malpositioned and required taking 9 patients back to the operating room for a second operation within the same admission to revise the malpositioned screws.8 of these patients were from cohort 1 (intraoperative x-ray verification) and 1 of the patients was from cohort 2 (intraoperative o-arm verification).2.In the first cohort, 5 patients had postoperative symptoms believed to be due to the malpositioned screws while 3 patients had no symptoms related to the malpositioned screws.The surgeon(s) decided to revise the non-symptomatic malpositioned screws because each of these screws either: (1) appeared to contact the left common iliac vein in one patient, (2) was directed into the right s1 nerve root in another patient, or (3) was significantly malpositioned with the tip terminating in the left paravertebral soft tissues in the last patient.3.In the second cohort (screws verified with o-arm), one patient required a revision surgery.The indication of the index procedure was kyphoscoliosis of the lumbar spine causing multilevel foraminal and canal stenosis.Intraoperatively, the medial deviation of the screw (l4) was noted on the intraoperative o-arm but the surgeon acknowledged in his operative note the misplaced screw but decided the leave the screw.The patient woke up with new dorsiflexion weakness postoperatively, and therefore, was taken back to the operating room for screw revision.Medtronic screws were used in this event.See attached literature article.

• 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: 15850784
• MDR Text Key: 304176931
• Report Number: 1030489-2022-01066
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2022

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?: Yes
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 11/23/2022
• 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): Required Intervention
• Patient Age: 54 YR