MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 6.0 X 45; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number 199721645

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional product code kwp;kwq;mnh;mni;osh.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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: it was reported that on (b)(6) 2020, a revision surgery was done because the patient had symptoms of back and leg pain and it was necessary more decompression.During surgery was detected that some screws didn¿t had fixation, they were loose.It was only in the beginning of the surgery that surgeon confirm that some screws were loose.It was unknown if the surgery was completed successfully.The patient outcome was unknown.Concomitant device reported: unknown rods (part# unknown, lot# unknown, quantity unknown ); unknown screws (part# unknown, lot# unknown, quantity unknown ).This complaint involves seven (7) devices.This report is for (1) 5.5 exp verse screw 6.0 x 45.This is report 3 of 7 (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: d10 h3, h4, h6: the device history record (dhr) of product code 199721645, lot 240964, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on may 02, 2019.H3, h6: a product investigation was completed: visual inspection of the complaint device showed the head of the screw was locked in the monoaxial position.Per the system guide, the polyaxial screw converts to a monoaxial screw upon tightening of the set screw.The system guide indicates that exceeding the system torque may result in failure of the implant.Upon loosening of the set screw, the screw head should become mobile again.A functional assessment was performed on the complaint device.The head of the screw was unable to be moved from the received position.The complaint condition of loose was unable to be replicated.The relevant drawings were reviewed; no design issues or discrepancies were identified.This complaint is not confirmed.The screw head is unable to move.A possible root cause is over-torqueing of the set screws, however no definitive root cause could be identified.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: 5.5 EXP VERSE SCREW 6.0 X 45
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10535687
• MDR Text Key: 207118594
• Report Number: 1526439-2020-01690
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034442273
• UDI-Public: 10705034442273
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199721645
• Device Catalogue Number: 199721645
• Device Lot Number: 240964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Date Manufacturer Received: 11/03/2020
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE SCREW 6.0 X 40; UNKNOWN RODS; UNKNOWN SCREWS
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR