MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG ZEVO ANTERIOR CERVICAL PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	G7703513
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were 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 that the patient presented with cervical spondylotic myelopathy; and underwent anterior cervical discectomy and fusion at c4-c6 and corpectomy was performed at c5.On an unknown date, post-op, the alleged screw along with 3 more screws backed-out.Sinking of a titanium mesh implant was also observed.The patient sometimes experienced right shoulder pain around the time when sinking of this mesh implant was reported.Hence, the patient underwent a revision surgery, in which all the 4 backed-out screws were removed and were replaced with longer screws.The anterior plate (that was inserted in the previous surgery) came off together with the screws and was used again by performing fixation with longer screws.Although there was sinking of mesh implant, it appeared to be fit in its position; hence, it was not removed and was left implanted in the patient's body."lms" was inserted from posterior side into c4-c6 and was fastened with rod and crosslink.

• Brand Name: ZEVO ANTERIOR CERVICAL PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• MDR Report Key: 10204277
• Report Number: 1030489-2020-00736
• Device Sequence Number: 13708067
• Product Code: KWQ
• UDI-Device Identifier: 00643169398504
• UDI-Public: 00643169398504
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141632
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2020

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: G7703513
• Device Lot Number: H5584468
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/27/2020
• 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: Required Intervention
• Patient Weight: 64