MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM TI OCCIPITAL SCREW 14MM; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	04.601.114
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: mni, mnh, and kwp.Complainant part is not expected to be returned for manufacturer review/investigation.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.(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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, a patient¿s rod broke, and a screw was loose.In (b)(6) 2018 a posterior cervical fusion was performed on the patient at o-c4.On an unknown date, the patient turned over in bed and heard cracking noise from the cervical area.On (b)(6) 2021 the patient went to see the surgeon, and it was found by ct, that the rod had broken off and the screw was loose.The patient has suffered from paralysis in the limbs since the event.On (b)(6) 2021 the patient is scheduled to undergo a revision procedure for rod replacement and screw-application-range extension.The surgeon evaluated the event¿s severity as ¿mild to moderate.¿ this report involves one (1) 4.5mm ti occipital screw 14mm.This is report 5 of 6 for (b)(4).

• Brand Name: 4.5MM TI OCCIPITAL SCREW 14MM
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11656997
• Report Number: 8030965-2021-02828
• Device Sequence Number: 3423482
• Product Code: NKG
• UDI-Device Identifier: 10705034734323
• UDI-Public: (01)10705034734323
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.601.114
• Device Catalogue Number: 04.601.114S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 04/13/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CANCELLOUSSCR SYNAPSE Ø3.5 L24 F/R Ø4 TA; CANCELLOUSSCR SYNAPSE Ø3.5 L28 F/R Ø4 TA; OCCIPIT-SCR Ø4.5 L12 TAN; OCCIPIT-SCR Ø4.5 L18 TAN; OCCIPIT-SCR Ø4.5 L4 TAN
• Outcome Attributed to Adverse Event: Required Intervention