MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM FIXED BOLT, STANDARD 6 X 40MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	175422640
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.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.
Event or Problem Description
It was reported that on an unknown date in (b)(6) 2021, during an l3 to l5 lumbar fusion plif procedure while final tightening, the locking nut on a expedium offset 6x40 mm screw.The surgeon sheared the top threads of the screw.The screw was removed and the sheared off portion of the screw was recovered.The screw was replaced with another 6 x 40 mm screw.No surgical delay reported.There was no patient consequence.The procedure was successfully completed by removing and replacing the screw.This report is for one (1) expedium spine system fixed bolt, standard 6 x 40mm.This is report 1 of 1 for (b)(4).

• Brand Name: EXPEDIUM SPINE SYSTEM FIXED BOLT, STANDARD 6 X 40MM
• Common Device Name: 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: 11563477
• Report Number: 1526439-2021-00529
• Device Sequence Number: 4183222
• Product Code: NKB
• UDI-Device Identifier: 10705034250656
• UDI-Public: (01)10705034250656
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 175422640
• Device Catalogue Number: 175422640
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/24/2021
• Patient Sequence Number: 1
• Patient Age: 70 YR