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

Device Problem Detachment Of Device Component (1104)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following literature article; trincat et al (2015): two-level lumbar total disc replacement: functional outcomes and segmental motion after 4 years.Orthopaedics & traumatology: surgery & research 101, pages 17¿21.France the goal of this study was to evaluate the perioperative complications and functional outcomes in patients who had undergone two-level lumbar tdr after a minimum follow-up of 2 years.The spinal segment motion was evaluated at the last follow-up using radiographs.A continuous series of 108 patients (51 women, 57 men) surgically treated over two levels with the prodisc-l implant was evaluated retrospectively with an average follow-up of 4 years.Ninety-three of these patients were operated for l4/l5 and l5/s1 degenerative disc disease, while 15 were operated for l3/l4 and l4/l5 disease.The procedure was carried out through the left retroperitoneal approach in 65 patients, the right retroperitoneal approach in 42 patients and both approaches in 1 patient.There was an 18% complication rate (all causes combined) for the entire series, which occurred in 15% of patients.Implant related complications were: 1 unclipping of polyethylene core and 2 implant subsidence (superior endplate of middle vertebra).Not implant-related complications were: 3 iliac vein wounds [2 left common iliac vein wounds (2 l4/l5¿l5/s1 using left approach), 1 right common iliac vein wound (1 l4/l5¿l5/s1 using right approach)]; 4 retroperitoneal hematoma; 1 l5 radicular deficiency; 1 dura mater wound; and 1 wound dehiscence.Early surgical revision was required in 2.8% of patients: one for unclipping of the uhmwpe insert and two for retroperitoneal hematoma secondary to letting go of vein sutures or ligatures.No late revisions were needed during the follow-up period.This is report 1 of 9 for (b)(4).This report is for an unknown pro-disc l implant, unknown lot, unknown quantity.A copy of the literature abstract is being submitted with this medwatch.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Trincat et al (2015): two-level lumbar total disc replacement: functional outcomes and segmental motion after 4 years.Orthopaedics & traumatology: surgery & research 101, pages 17¿21., this report is for an unknown pro-disc superior endplate, unknown lot, unknown quantity.Udi # unknown part number, udi is unavailable.(b)(6) one unclipping of polyethylene core; patient revised.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: 4780320
• MDR Text Key: 5817453
• Report Number: 2530088-2015-10367
• 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

• 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
• Initial Date Manufacturer Received: 04/28/2015
• Initial Date FDA Received: 05/19/2015
• 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