MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 6.0 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 199721645

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2022

Event Type  malfunction  

Event Description

Device report from china reports an event as follows: it was reported that during a procedure for lumbar spondylolisthesis on (b)(6) 2022, after the verse screw was implanted, the screw became locked and could not be rotated while the screw cap was not fixed.The surgeon removed the locked screws from the patient and replaced them with devices of other brands to complete the procedure, prolonging the surgery for approximately 3 hours.There is no patient outcome.This report is for a expedium verse spine system polyaxial screw 5.5 6.0 x 45mm.This is report 2 of 3 for (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.Additional procode: mni, kwq.Kwp, mnh, 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 conclusion could be drawn, as no product was received.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.

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.Additional narrative: subsequent follow-up with the customer, additional information was received regarding the event.It was reported that there were no adverse patient consequences nor medical intervention required.Investigation summary - both photo of the alleged device and the actual device were received for evaluation.Visual analysis of the photo revealed that the head of the 5.5 exp verse screw 6.0 x 45 appears to be crooked, however the unable to disassemble condition can not be assessed through a photo investigation.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the 5.5 exp verse screw 6.0 x 45, p/n:(b)(6), appears to have markings consistent with the implantation and explantation process.A dimensional inspection was unable to be performed due to device design.A functional test to unlock the verse screw was conducted using a t25*4" stardrive screwdriver and the screw was successfully unlocked.The overall complaint was not confirmed as the 5.5 exp verse screw 6.0 x 45, p/n:(b)(6) was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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 history review - a manufacturing record evaluation was performed for the finished device: product code: 199721645, lot number: 297428; and no non-conformances / manufacturing irregularities were identified during the manufacturing process.

• Brand Name: EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 6.0 X 45MM
• 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
• 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: 15007734
• MDR Text Key: 296259095
• Report Number: 1526439-2022-01044
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034442273
• UDI-Public: (01)10705034442273
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199721645
• Device Catalogue Number: 199721645
• Device Lot Number: 297428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE SCREW 6.0 X 45.; 5.5 EXP VERSE SCREW 6.0 X 45.