MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SINGLE-INNER SETSCREW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 179702000

Device Problem Device Slipped (1584)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional procode: kwp;kwq;mnh;mni;osh.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.Investigation summary complaint summary: it was reported that on an unknown date, a female patient stated felt a ¿clunking¿ in the left side of her posterior lumbar spinal fusion surgery after her surgery on (b)(6) 2020.She received a follow up ct scan to show that the rod on her left l3 vertebrae has migrated but was still captured in the tulip.Currently, no other systems and no plan for revision surgery.Patient and procedure outcome were unknown.The implant(s) was not returned and instead the investigation will be done based on the supplied image(s).The image(s) was reviewed and the complaint condition could not be confirmed.As the implant(s) was not returned an as received condition, dimensional inspection, material or drawing reviews are not applicable.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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

It was reported that on an unknown date, a female patient stated she felt a ¿clunking¿ in the left side of her posterior lumbar spinal fusion surgery after her surgery on (b)(6) 2020.She received a follow up ct scan that showed that the rod on her left l3 vertebrae has migrated but was still captured in the tulip.Currently, no other systems and no plan for revision surgery.Patient and procedure outcome were unknown.Concomitant device reported: unknown pedicle screw (part# unknown, lot# unknown, quantity unknown).This report is for one (1) single-inner setscrew.This is report 1 of 2 for (b)(4).

Event Description

Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity 3), unknown rod (part# unknown, lot# unknown, quantity 1).

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.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: SINGLE-INNER SETSCREW
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10586828
• MDR Text Key: 208551632
• Report Number: 1526439-2020-01794
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034064307
• UDI-Public: (01)10705034064307
• Combination Product (y/n): N
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179702000
• Device Catalogue Number: 179702000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2020
• Patient Sequence Number: 1
• Treatment: UNKNOWN RODS; UNKNOWN RODS; UNKNOWN SCREWS; UNKNOWN SCREWS; UNKNOWN RODS; UNKNOWN SCREWS
• Patient Outcome(s): Required Intervention