MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC UNKNOWN

Model Number MSB_UNK_UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Spinal Column Injury (2081)

Event Date 01/05/2021

Event Type  Injury  

Event Description

Summary: instrumented posterior fusion using pedicle screws has been the mainstay of the surgical correction of adolescent idiopathic scoliosis (ais).The aim of this case report is to describe the occurrence and salvage of an l1 chance fracture occurring through the lower instrumented vertebra (liv) following pedicle screw placement for posterior spinal instrumented fusion in the treatment of ais.This case shows that there must be due consideration of the small pedicle at l1 when it is chosen as the liv.Reported events: 1.Instrumented posterior spinal fusion with pedicle screws is the most commonly employed surgical treatment for adolescent idiopathic scoliosis (ais).In lenke type 1 or 2 curves, l1 is commonly the lowest instrumented vertebra (liv); however, the l1 vertebra has small pedicles which challenges its safe instrumentation.Surgery.Here is the case of a patient treated with posterior spinal fusion for ais who sustained a chance fracture at l1 following t2¿l1 posterior instrumented fusion for ais.2.A patient presented with a lenke 1b deformity complaining of back pain and a feeling of leaning to the right.Examination showed an elevated right shoulder, right trunk shift and normal neurology.A diagnosis of ais and a recommendation for posterior spinal fusion of t2¿l1 was made based upon bending radiographs.No pre-operative ct scan was carried out.The patient was advised of the risks of construct failure and the potential for revision surgery.3.Legacy titanium (medtronic minneapolis, mn) instrumentation was used with fixed angle screws placed at t3¿l1, and polyaxial screws placed at t2.The location of each screw was confirmed with electromyography.There were no intraoperative concerns with pedicle screw position or size, and no fracture or perforation of the pedicle was noted.Post-operative radiographs showed a residual main thoracic coronal curve and satisfactory sagittal alignment.48°.There were no immediate or early complications.4.At 6 months post-operatively, the patient complained of pain in the lower back and an associated bump.Radiographs showed new lumbar kyphosis between t12 and l2 consistent with a chance fracture at l1.The patient underwent extension of fusion to l3 and made an uneventful recovery.At 5-year follow-up, the patient is well and participating in unrestricted sports.The following device specifics were provided: legacy titanium (medtronic minneapolis, mn) instrumentation was used with fixed angle screws and polyaxial screws see attached literature article.

Manufacturer Narrative

Date of event: please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.Section d information references the main component of one of the systems involved in the reported events.Product identifiers are unknown for legacy titanium (medtronic minneapolis, mn) instrumentation.Product identifier is unknown, hence 510k# is not available.Rocos, b., kato, s., lebel, d., lewis, s.A bony chance fracture through l1 following posterior spinal fusion for adolescent idiopathic scoliosis: a case report.Spine deformity.2021.9:859-862.Doi.10.1007/43390-020-00257-4.This mdr is being filed for notification purpose only.No clear allegations on product malfunction is available.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 14191769
• MDR Text Key: 289953298
• Report Number: 1030489-2022-00387
• Device Sequence Number: 1
• Product Code: OSH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_UNKNOWN
• Device Catalogue Number: MSB_UNK_UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Sex: Female