MAUDE Adverse Event Report: SYNTHES BRANDYWINE; PROSTHESIS INTERVERTEBRAL DISC

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

Patient Problems Hematoma (1884); Laceration(s) (1946); Pain (1994); Reaction (2414); No Code Available (3191)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following literature article; bertagnoli r (2006) ¿lumbar total disc arthroplasty utilizing the prodisc prosthesis in smokers versus nonsmokers: a prospective study with 2-year minimum follow-up.¿¿ pmid: 16641775 [pubmed - indexed for medline] spine vp;i,e 31, number 9, pp 992-997 2006, lippincott williams & wilkins, inc.This article reports on whether or not smoking is a negative predictor in fusion surgery.A prospective analysis was performed on 104 patients with disabling discogenic low back pain treated with single-level lumbar prodisc l total disc arthroplasty.34 smokers and 70 nonsmokers were assessed before surgery and after surgery using patient satisfaction.Additionally, preoperative and postoperative neurologic, radiographic, and pain medication assessments were performed at similar postoperative intervals.The results state patient satisfaction scores revealed statistical improvement beginning 3 months after surgery and were maintained at minimum 2-year follow-up.No cases of loosening dislodgement, mechanical failure, infection, or fusion of the affected segment occurred.Complications reported: intro-operatively there were 2 retroperitoneal hematomas requiring drainage and bladder laceration.Posy-operatively one patient had persistent leg pain following l5-s1 implant that required posterior exploration and decompression that revealed posterior subauricular stenosis.This patient was unsatisfied with her outcome at 32 months post procedure.This is report for 2 of 3 items for (b)(4).Udi # unknown part number, udi is unavailable.This report is for an unknown prodisc l inferior implant, unknown part/unknown lot number.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Bertagnoli r (2006) ¿lumbar total disc arthroplasty utilizing the prodisc prosthesis in smokers versus nonsmokers: a prospective study with 2-year minimum follow-up.¿¿ pmid: 16641775 [pubmed indexed for medline] spine vp;i,e 31, number 9, pp 992-997 2006, lippincott williams & wilkins, inc.This report is for unknown inferior endplate prodisl implant , unknown quantity, unknown item number and unknown lot number.Udi # unknown part number, udi is unavailable.(b)(6).(b)(4).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: 4777208
• MDR Text Key: 20018029
• Report Number: 2520274-2015-13762
• 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: 05/18/2015
• 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