MAUDE Adverse Event Report: SYNTHES BRANDYWINE; PROSTHESIS INTERVERTEBRAL DISC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Abscess (1690); Bacterial Infection (1735); Fever (1858); Nausea (1970); Pain (1994); Vomiting (2144); Impaired Healing (2378); No Code Available (3191); Constipation (3274)

Event Date 11/25/2009

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article: spivak, j., et al.(2010).Revision of a lumbar disc arthroplasty following late infection.Eur spine j, 19:677-681.Usa.The study objective was to review a case involving an unusual late retroperitoneal abscess following two-level total disc replacement (tdr) with direct extension to one of the implants, and the subsequent non-operative and operative management.The patient was a (b)(6) male who underwent an uncomplicated two-level total disc replacement (tdr) at l4-l5, l5-s1 on an unknown date with prodisc-l as part of fda-approved continued access following enrollment completion of the two-level arm of the prodisc-l multi-centered ide study.The study compared circumferential fusion in patients with one and two-level discogenic disc disease.The patient presented again 8 months after surgery complaining of severe, sharp back, abdominal, and left thigh pain of acute onset.He was febrile to 102 with complaints of nausea and vomiting, and had constipation for the preceding 8 days.A left psoas-based retroperitoneal abscess at l4-5 was diagnosed by a ct scan, and it was percutaneously drained.Purulent exudate was excavated and sent for culture and sensitivity, and a pigtail catheter was left in situ.Cultures from blood revealed streptococcus intermedius.The patient was discharged from the hospital with a picc line and appropriate antibiotics.His severe abdominal pain improved, but low back persisted.The patient was recommended suppressive antibiotics for 4-6 months.The patient was revised at five (5) months following presentation of the infection, or thirteen (13) months following his index tdr surgery.The two (2) implants were removed and the patient was revised to a two-level fusion with an autograph spacer packed with infuse-bmp2, an unknown 6.5 mm screw, washer, and pedicle fixation.The reoperation was uneventful.Four years postoperatively, the patient has an excellent fusion with no signs of infection and has some persistent low back pain and retrograde ejaculation.This is report 2 of 3 for (b)(4).This report is for unknown prodisc-l implants, unknown part # / lot #.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Udi # unknown part number, udi is unavailable.This report is for unknown prodisc-l implants (polyethylene inlay), unknown quantity / unknown lot.(b)(6).(b)(4).Persistent retrograde ejaculation, antibiotics.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: 4780191
• MDR Text Key: 5880166
• Report Number: 2530088-2015-10284
• 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: 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: 05/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Patient Age: 35 YR