MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 4.0 PLY SCRW 3.5X12; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	1020-35-112
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/18/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Additional narrative: additional procode: kwp.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.(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 or Problem Description
It was reported that (b)(6) 2020 during posterior cervical fusion surgery the patient died.The depuy synthes spine system utilized in this procedure was the symphony oct system.The instrumentation of the symphony screws was uneventful.The surgeon first instrumented c4-6 lateral masses, then c2 pars, and finally t1 pedicles.All screw placements were confirmed by the surgeon with fluoroscopy.The surgeon proceeded to perform the decompression with a c3-7 laminectomy.Afterwards the surgeon changed the vector of the patients head to re-align the spine after decompression.Approximately ten (10) minutes afterwards he began preparing two (2) 4.0mm rods.Prior to instrumentation of the rods, the patient began to lose sensory neuromonitoring signals.Approximately five (5) minutes later the patient loses motor signals and low blood pressure.At this moment there is an urgency to complete the construct and close the patient.The surgeon decided to use 3.5mm rods instead.All rods and set screws were implanted and final tightened as intended.The patient went into cardiac arrest approximately 5 minutes into closing.Approximately 1 hour afterwards, time of death was announced.There was no surgical delay.The procedure was successfully completed.Concomitant device reported: unknown setscrews (part# unknown, lot# unknown, quantity unknown) this report is for one (1) 4.0 ply scrw 3.5x12.This is report 4 of 4 for (b)(4).This report is linked to (b)(4).
Additional 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.H10 additional narrative: d6a: updated implantation date e1 : updated initial reporter name 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: 4.0 PLY SCRW 3.5X12
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11177399
• Report Number: 1526439-2021-00158
• Device Sequence Number: 4086004
• Product Code: NKG
• UDI-Device Identifier: 10705034508689
• UDI-Public: 10705034508689
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K181949
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1020-35-112
• Device Catalogue Number: 102035112
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 02/05/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN LOCKING/SET SCREWS; UNKNOWN LOCKING/SET SCREWS
• Outcome Attributed to Adverse Event: Death
• Patient Age: 80 YR