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

Catalog Number 04.647.836

Device Problems Material Integrity Problem (2978); No Apparent Adverse Event (3189)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Only event year is known.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter address: (b)(6).Reviewing the picture: the received x-ray confirms the issue as per event description, that the holding plate of zero-p cage is broken off as well as an cervic-spine-screw is back out of the plate.The complaint therefore has been determined to be confirmed.Just based on the picture it is not possible to confirm a functional issue.As the lot number is unknown we are not able to research the device history record and the manufacturing documents.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the plate for the zero-p implant broke.The patient experienced pain, and an x-ray showed that the plate was broken.The patient was offered a revision procedure.Patient outcome was unknown.Concomitant devices reported: zero-p va cage convex h7 peek (part number 04.647.137s, lot 4l76505, quantity 1); cervic-spine-scr ø3.7 self-drill 16 tan (part number 04.647.836, lot unknown, quantity 1).This report involves one (1) 3.7mm ti cervical spine screw slf-drlg/variable angle 16mm.This is report 2 of 3 for (b)(4).

Event Description

The initial complaint was reviewed and found not reportable.There was no allegation reported against the screws.They are concomitant to manufacturer report number 8030965-2021-01309.

• Brand Name: 3.7MM TI CERVICAL SPINE SCREW SLF-DRLG/VARIABLE ANGLE 16MM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11373570
• MDR Text Key: 242732985
• Report Number: 8030965-2021-01311
• Device Sequence Number: 1
• Product Code: OVE
• UDI-Device Identifier: 07611819386693
• UDI-Public: (01)07611819386693
• Combination Product (y/n): N
• PMA/PMN Number: K112068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.647.836
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/16/2021
• Patient Sequence Number: 1
• Treatment: CERVIC-SPINE-SCR Ø3.7 SELF-DRILL 16 TAN; ZERO-P VA CAGE CONVEX H7 PEEK
• Patient Outcome(s): Required Intervention