MAUDE Adverse Event Report: DEPUY SPINE INC UNKNOWN PLATES; PLATE,FIXATION,BONE

Device Problem No Apparent Adverse Event (3189)

Patient Problems Calcium Deposits/Calcification (1758); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.(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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: a comparison of anterior cervical corpectomy and fusion combined with artificial disc replacement and cage fusion in patients with multilevel cervical spondylotic myelopathy authors: ningfang mao , md, jinhui wu , md, ye zhang , md, xiaochuan gu , md , yungang wu , md, chunwen lu , md , muchen ding , md, runxiao lv , md, ming li , md , and zhicai shi , md citation: spine 2015;40:1277¿1283; doi: 10.1097/brs.0000000000000957.The aim of this retrospective study was to compare clinical and radiological outcomes of anterior cervical corpectomy and fusion (accf) combined with artificial disc replacement (c-adr) and accf combined with anterior cervical discectomy and fusion (acdf) in patients with consecutive 3-level cervical spondylotic myelopathy (csm).Between june 2007 to august 2011, a total of 42 patients were divided into 2 groups.Group a (n = 19 (12 males and 7 females); age: 47.6 ± 7.6) underwent accf combined with 1-level c-adr; group b (n = 23 (13 males and 10 females); age: 48.7 ± 7.4) underwent accf combined with 1-level acdf.During the accf procedures, tmc (depuy spine, (b)(4), usa) plus semiconstrained plating systems (slimloc; depuy spine, (b)(4), usa) were used.For the acdf procedures, cages (bengal; depuy spine, (b)(4), usa and synthes (b)(4)) were used.For the c-adr procedures, a prodisc-c (synthes , (b)(4)) was used.Complications included heterotopic ossification developed in 2 group a patients.One is a 47-year male patient who presented with multilevel cervical spondylotic myelopathy showed heterotopic ossification in c6¿c7 (adr) 2 years after operation.One group b patient showed transient hoarseness.Infection, screw loosening, plate fracture, and device migration were not identified.Based on the results of the present study, both accf hybrid c-adr and accf hybrid acdf provide satisfactory clinical and radiological outcomes for 3-level gsm.Accf hybrid 1-level c-adr is superior in terms of better ndi recovery, less intermediate term neck and arm pain, and better c2¿c7 rom recovery.This procedure may be a suitable choice for the management of 3-level csm in appropriate patients." the following complications were reported as follows: 1 patient with heterotropic ossification, 1 patient with transient hoarseness.Depuy spine product: this report is for semiconstrained plating systems (slimloc; depuy spine, (b)(4)).This is report 2 of 3 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Surgical intervention in the form of revision surgery.Eye movement disorder.

• Brand Name: UNKNOWN PLATES
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9437670
• MDR Text Key: 185603926
• Report Number: 1526439-2019-52645
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention