MAUDE Adverse Event Report: SYNTHES USA

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Seroma (2069); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

Journal article received: early experience treating thoracic disc herniations using a modified transfacet pedicle-sparing decompression and fusion; richard bransford, fangyi zhang, carlo bellabarba, mark konodi, and jens r.Chapman; j neurosurg; department of orthopaedics and sports medicine, harborview medical center and department of neurosurgery, university of washington.: j neurosurg spine 12:221¿231, 2010; reported: the objective of this study was to assess outcomes and complications in a consecutive series of patients with thoracic disc herniations undergoing posterior transfacet decompression and discectomy with posterior instrumentation and fusion.Segmental fixation was performed with the universal spine system (synthes).Interbody arthrodesis was accomplished with machined freeze-dried allograft t-plif spacers (synthes).The average t-plif height was 9mm (range 7-15mm).Arthrodesis was carried out with a mixture of local bone graft derived from the neural element decompression, tricalcium phosphate pellets (chronos, synthes), demineralized bone matrix allograft (dbx, synthes), and autologous blood.Care was taken to ensure that approximately half of the graft material was composed of morcellized local bone graft.Results: eighteen consecutive patients with 29 symptomatic thoracic disc herniations were treated with a modified transfacetal, pedicle-sparing decompression and segmental reconstruction and fusion.The mean age of the patients was 50 years (range 27-71 years) and 11 of 18 were men.Three patients had postoperative infections.In all 3 cases, prolonged postoperative wound drainage required reoperation despite appropriate preoperative and postoperative intravenous antibiotic therapy.Each patient had positive bacterial cultures and responded successfully to operative irrigation and debridement and appropriate antibiotic therapy.An additional patient developed a large seroma that required percutaneous drainage under ct guidance.In another patient, postoperative imaging revealed an excessively long screw at t-6 in close proximity to the aorta.This patient also had a suboptimally placed allograft spacer within the t6-7 disc space and underwent an uneventful reoperation for repositioning of the left t-6 screw and the t6-7 allograft spacer on the second postoperative day; he was subsequently discharged 8 days after his original surgery.Two of the three patients who developed post-operative infections were at increased risk due to morbid obesity with body mass index greater than 35.Another patient was at increased risk due to poorly controlled diabetes.Conclusion: a modified transfacetal pedicle-sparing approach combined with short segmental fusion offers a safe means of achieving concurrent decompression and segmental stabilization and is an option for certain subtypes of thoracic disc herniation.Although 5 patients required additional surgery for postoperative complications, all patients experienced improvement relative to their preoperative status.This report is for an unknown spacer.This report is 5of 6 for (b)(4).

Manufacturer Narrative

Device is used for treatment, not diagnosis.Date of event: j neurosurg spine 12:221¿231, 2010.Device is an unknown spacer, quantity 1.Investigation could not be completed, no conclusion could be drawn as no device was returned and no lot number was provided.Manufacturing records could not be reviewed without a lot number.

• Manufacturer (Section D): SYNTHES USA; west chester PA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 8006207025
• MDR Report Key: 3648459
• MDR Text Key: 4349203
• Report Number: 2520274-2014-00856
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• 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: 01/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention