MAUDE Adverse Event Report: SYNTHES BRANDYWINE; PROSTHESIS, INTERVERTEBRAL DISC

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Literature article received.This report is being filed after the subsequent review of the following literature article: siepe, c., mayer, m., wiechert.K., korge.A.(2005).Clinical results of total lumbar disc replacement with prodisc ii.Spine, volume 31, pp 1923 ¿ 1932.((b)(4)).This article is for a prospective study analyzing midterm clinical results of total lumbar disc replacement (prodisc ii) for different indications in order to assess functional outcome after total lumbar disc replacement (tdr) treated for varying indications.The study design was a prospective, nonrandomized study from (b)(6) 2000 to (b)(6) 2005 of 92 patients.Patients were divided into four groups according to their preoperative diagnosis- group 1: degenerative disc disease (ddd), group 2: ddd plus disc hemiation, group 3: post ¿ discectomy, and group 4: ddd plus modic.Patients were examined and patient data was collected before surgery, 3-months post-operatively, 6-months post-operatively, 12- months post-operatively, and annually from then on.All patients were nonresponders to a preoperative intensive conservative inpatient and outpatient treatment program.Low back pain (lbp) was the predominant and leading complaint in all patients.Eighteen of the patients (19.6%) experienced complications.Eighteen patients (19.6%) experienced complications.The following complications were intraoperative: retrograde ejaculation (2 patients- 1 persisting and 1 temporary), and sympathectomy related dysesthesia (1 patient).The following complications were postoperative: deep vein thrombosis + arterial pulmonary embolism + lysis (1 patient- patient with known coagulopathy), and superficial wound healing impaired (1 patient).The following complications were postoperative: extraforaminal disc protrusion following tdr (1 patient- spontaneous improvement upon conservative therapy), neuropathy l5 (1 patient), heterotopic ossification (1 patient- type iii mcafee classification), intraoperative/postoperative complications total (8 patients), reoperations (8 patients), primary suboptimal implantation (1 patient- secondary dislocation + fusion), inlay dislocation (1 patient ¿ implant replaced), implant subsidence (2 patients ¿ secondary fusion operation), segmental hyperlordosis persisting problems (1 patient, posterior dynamic fixation (dynesis)), persisting facet joint problems (2 patients ¿ secondary fusion), secondary spinal canal stenosis (1 patient ¿ microsurgical decompression), and reoperations- adjacent segment disc herniation (2 patients- microsurgical discectomy).This is report 6 of 6 for (b)(4).This report is for an unknown prodisc-ii device, unknown part#/lot#.A copy of the literature article is being submitted with this medwatch.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: this report is for an unknown prodisc-ii polyethylene inlay/unknown quantities/unknown lot.Udi: unknown part number, udi is unavailable.(b)(6).The investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4771506
• MDR Text Key: 5776996
• Report Number: 2530088-2015-10158
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PP050010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention