MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VERSE CORRECTION KEY; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 199721000

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

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); Paralysis (1997); Injury (2348); Unspecified Nervous System Problem (4426)

Event Date 06/26/2018

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown locking/set screw/unknown lot.Part and lot number 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

On (b)(6) 2015 the patient presented with shoulder pain.Radiological studies revealed scoliosis however, they failed to diagnose scoliosis or have the patient scoliosis evaluation.On (b)(6) 2018 the patient presented with upper back pain primarily in the left-mid-thoracic spine radiating to the left and right buttocks.The pain was intermittent, moderate aches with no history of back pain before.On (b)(6) 2018 the patient explained that she had low back pain and occasional thigh pain.The patient did not have radiating pain, numbness or tingling in her extremities.The patient was scheduled for a posterior instrumented fusion of t2 to l4 vertebral bodies.The need for the surgery was urgent because it was not detected earlier.On (b)(6) 2018 the surgeon recommended and agreed to have urgent surgery with more conservative treatment.On (b)(6) 2018 a posterior instrumented fusion t2 to l4 was performed and the patient awoke from the surgery.The patient was completely paralyzed from her chest down with the motor-sensory loss from t4 to her toes and now suffers from dysreflexia.This report is for one (1) unknown locking/set screw.This is report 2 of 4 for (b)(4).This complaint is linked to (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Investigation summary: 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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.D2: additional product codes: mni, kwp, nkb, kwq, and osh.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

Additionally it was reported that on (b)(6) 2018 patient a subsequent removal of spinal hardware including bilateral rods, t2 hooks bilaterally, right t5 screw and left t9 and t10.This intervention was noted for partial correction of patient's deformity.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: b5 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.

• Brand Name: VERSE CORRECTION KEY
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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 ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 10048706
• MDR Text Key: 193333135
• Report Number: 1526439-2020-01026
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466132
• UDI-Public: 10705034466132
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 199721000
• Device Catalogue Number: 199721000
• Device Lot Number: 317609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2022
• 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
• Treatment: SINGLE-INNER SETSCREW.; SINGLE-INNER SETSCREW.; VERSE CORRECTION KEY.
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR
• Patient Sex: Female