MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Fatigue (1849); Nerve Damage (1979); Paralysis (1997); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unknown screw/rod construct accessories/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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 synthes reports an event in japan as follows: this report is being filed after the review of the following journal article: funayama, t.Et al (2021), severe, rigid cervical kyphotic deformity associated with sapho syndrome successfully treated with three-stage correction surgery combined with c7 vertebral column resection: a technical case report, spine deformity, vol.9 (xx), pages 285292 (japan).This study presents a case report of a (b)(6) year-old female patient who had been diagnosed with cervical kyphotic deformity associated with sapho syndrome.She had difficulty looking upward.On radiography, the c4c7 vertebral bodies were fused and exhibited severe rigid kyphotic deformity.Right convex scoliosis with a cobb angle of 22¿ was apparent at c5t2, and the c2c7 angle of kyphosis was 75¿.Corrective three-stage surgery was carried out from the anterior, posterior, and anterior, with c7 vertebral column resection (vcr).Surgery was performed using mountaineer (depuy synthes, ma, usa).Paralysis of the upper extremity on one side appeared on postoperative day 2, consisting of numbness and weakness of the left arm.Manual muscle testing (mmt) scores were shoulder abduction: 3, elbow flexion: 3, wrist dorsiflexion: 2, elbow extension: 2, finger extension: 2, and finger abduction: 3, indicating left c5c8 nerve root damage.In postoperative week 2, shoulder abduction and elbow flexion began to improve, but the other mmt scores all worsened to 1.After 1 month of rehabilitation with the hybrid assistive limb (hal) system, the mmt scores started to improve again at around 2 months postoperatively, and by 6 months postoperatively they had fully recovered.Partial paralysis of the fibular nerve also appeared as an immediate postoperative complication but improved within 1 month.This report is for an unknown depuy spine mountaineer screw/rod construct.This report is for (1) unknown screw/rod construct accessories.This report is 1 of 1 for (b)(4).

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12100504
• MDR Text Key: 266307538
• Report Number: 1526439-2021-01374
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• 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: 06/09/2021
• 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): Required Intervention
• Patient Age: 22 YR