MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM

Catalog Number	G6623515
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Intervertebral fusion device with integrated fixation, cervical product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported on (b)(6) 2017 the patient underwent anterior cervical decompression and fusion at c4/5 due to cervical spondylotic myelopathy.Post-op, at the time of x-ray inspection of the one month after surgery, screw back out was observed.Ct was taken to confirm and it was judged that the screw had backed out at cranial side of c4/5.In revision surgery, it was found the locking cap was locked, but the locking cap was not put on the relevant screw.The surgeon released the lock mechanism and tightened the screw, and then turned the locking cap to conclude.The hospitalization period was prolonged to due revision surgery.
Additional Manufacturer Narrative
Post-op x-rays for 2 level acdf done with divergence standalone interbody grafts.At the bottom level, there was back out of the superior screw.By report this is because the locking mechanism was not properly tightened.This also falls outside of the indication for use as this is indicated for single level only.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 7081870
• Report Number: 1030489-2017-02447
• Device Sequence Number: 19150495
• Product Code: OVE
• UDI-Device Identifier: 20643169338801
• UDI-Public: 20643169338801
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2018

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 Catalogue Number: G6623515
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 12/05/2017
• Supplement Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention