MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: EXPEDIUM; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Pain (1994); Numbness (2415)

Event Date 05/20/2022

Event Type  Injury  

Manufacturer Narrative

Pma/510k: this report is for an unknown device/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from (b)(6) reports an event as follows: this report is being filed after the review of the following journal article: takeda k., et al (2022) postoperative loss of correction after combined posterior and anterior spinal fusion surgeries in a lumbar burst fracture patient with class obesity, surgical neurology international volume 13(210), pages 1-7 (japan).This study presents a case report of a patient of lumbar (l1) burst fracture in a patient with class ii obesity who was treated with combined multi-level posterior and single-level anterior fusion surgery but failed to maintain favorable local thoracolumbar sagittal alignment.A 28-year-old man brought to the emergency room with a lumbar burst fracture at the l1 level caused by a fall from a 6-m height.Patient had class ii obesity (height, 178 cm; weight, 117 kg; and bmi, 36.9 kg/m2).He complained of severe back pain, bilateral lower-extremity pain, and numbness.Although accurate neurological evaluation was difficult because of severe back and lower extremity pain, the weakness of the bilateral lower extremities (medical research council grade 3¿4) and no sensory decline by the pin-prick test was observed.Initial radiographic examination including computed tomography (ct) scan and magnetic resonance imaging showed burst fracture at the l1 level with spinal cord and cauda equina compression, which was classified as ao type b2 with spinous process fracture at l1 and l2.The first surgery was performed 2 days after the trauma.During the surgery, pedicle screws (universal spine system ii, depuy synthes, zuchwil, switzerland) were inserted.Vacant space inside the fractured vertebra was filled with hydroxyapatite blocks (pentax, tokyo, japan).Postoperatively, the patient¿s back and lower extremity symptoms improved when compared with preoperatively; however, the patient was unable to stand because of severe back pain in the standing position.Eight days after surgery, the patient was able to stand; thus, radiographs of the thoracolumbar spine were taken in the standing position 14 days after the surgery.Local kyphosis angle (lka) was 32° in the standing position, while it was 24° in the lateral lying position.Sufficient stability could not be achieved by 1-above 1-below posterior fusion.Therefore, we conducted additional surgery to achieve better stability of the unstable t12-l2 segments.Twenty-two days after the first surgery, a second surgery was performed.All implants, including pedicle screws inserted at the first surgery, were removed, and pedicle screws of other systems (expedium spine system, depuy synthes, zuchwil, switzerland) were inserted at the t10, t11, t12, l2, l3, and l4 levels.On each side, the pedicle screws from t10 to l4 levels were connected by two rods to reinforce the stability of the screw-rod system.Ten days after the second surgery, the patient could stand and walk by himself with a hard thoracolumbar orthosis in the horizontal bars with mild back pain and slight bilateral foot numbness.The local kyphosis angle (lka) was 22° in the lateral lying position and 27° in the standing position.Forty-four days after the second surgery, a third surgery was performed where the left eleventh rib was harvested, and the left lateral aspect of the t12-l1 vertebra was exposed through the retropleural approach.After the third surgery, the local kyphosis angle (lka) was 22° in the lateral lying position and 29° in the standing position.The postoperative course after the third surgery was favorable, with no postoperative complications.Back pain gradually decreased postoperatively, and the muscle weakness of the lower extremities returned to normal; however, slight residual back pain and foot numbness remained after the third surgery.Twenty-one months after the third surgery, complete bony fusion at the t12-l1 segment was confirmed by ct images; thus, 24 months after the third surgery, all posterior implants were surgically removed.The local kyphosis angle (lka) in the standing position was 28° before removal and 30° 11 days after removal.Before implant removal, no correction loss in the local kyphosis angle (lka) in the standing position occurred after the third surgery.However, an increase of 6° in local kyphosis angle (lka) in the lateral lying position was observed after the third surgery; thus, lka in the lateral lying position was the same as that in the standing position when bony fusion between t12 and l1 was achieved.After implant removal, obvious loss of lordosis at the t12-l2 segments was observed.Six months after the removal, lka in the standing position was 37°, and increased up to 40° at the final follow-up (27 months after removal.Complete bony fusion between the l1 and l2 vertebrae was observed, as well as between t12 and l1.Loss of lordosis occurred both at the t12-l1 segment (6°) and l1-l2 segment (6°), although continuous trabecular bone formation between the t12 and l1 vertebrae was observed before implant removal.At the final follow-up (27 months after the removal), the patient was able to walk and jog without any support; however, slight back pain and slight left foot numbness were reported.At the final follow-up (27 months after the removal), the patient was able to walk and jog without any support; however, slight back pain and slight left foot numbness were reported his activities of daily life had returned to normal and started work in the construction industry.This report is for an unk - construct: expedium.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: EXPEDIUM
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 14979645
• MDR Text Key: 295641718
• Report Number: 1526439-2022-01007
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 117 KG