MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.7MM TI CERVICAL SPINE SCREW SLF-DRLG/VARIABLE ANGLE 16MM; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

Model Number	04.647.836
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age and weight were not provided for reporting.Device was implanted.Explant date is not applicable.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, patient underwent a cervical 5/6 anterior cervical discectomy and fusion (acdf) surgery.During the surgery while the surgeon was implanting screws, a superior screw was locked off due to the stardrive shaft being stripped and not able to engage in the head of the screw.The blocking screw was not engaged.Screw was not locked off.The inferior screw was locked but it was also stripped.The surgeon tried to use the same product, stardrive screwdriver shaft but it failed.Both stardrive screwdriver shafts were not functioning and could not be used.The procedure was completed successfully.There was a ten-minute surgical delay.There was no adverse effect to the patient.The patient was stable.This report is for one (1) 3.7mm ti cervical spine screw slf-drlg/variable angle 16mm.This is report 3 of 4 for (b)(4).

• Brand Name: 3.7MM TI CERVICAL SPINE SCREW SLF-DRLG/VARIABLE ANGLE 16MM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7732811
• Report Number: 8030965-2018-55374
• Device Sequence Number: 19183757
• Product Code: OVE
• UDI-Device Identifier: 10705034751368
• UDI-Public: (01)10705034751368
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2018

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: 04.647.836
• Device Catalogue Number: 04.647.836
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 07/30/2018
• Patient Sequence Number: 1