ORTHOSIS, SPINAL PEDICLE
Report
- Report Number
- 2520274-2014-12889
- Event Type
- Injury
- Date Received
- July 31, 2014
- Report Date
- July 13, 2014
- Manufacturer
- SYNTHES USA
- Product Code
- NKB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHARMACIST
Narratives
IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. LITERATURE CITATION: JEFFREY D. COE, MD ET AL: NFLEX DYNAMIC STABILIZATION SYSTEM: TWO-YEAR CLINICAL OUTCOMES OF MULTI-CENTER STUDY PUBLISHED IN THE JOURNAL OF KOREAN NEUROSURGICAL SOCIETY 51: 343-349, 2012. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF A PANGEA LOCKING CAP WITH AN UNKNOWN PART AND LOT NUMBER. NFLEX IS NOT CURRENTLY AVAILABLE FOR THE US MARKET; HOWEVER, IT IS AVAILABLE IN THE OUS MARKET. THE NFLEX STABILIZATION SYSTEM IS INTENDED FOR USE WITH PEDICLE SCREW FIXATION IN SKELETALLY MATURE PATIENTS TO PROVIDE CONTROLLED DYNAMIC STABILIZATION OF THE LUMBOSACRAL SPINE. SIMILAR STABILIZATION SYSTEMS ARE AVAILABLE IN THE US MARKET THUS THIS COMPLAINT IS BEING REPORTED. (B)(4). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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.
DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ORIGINALLY REPORTED PANGEA SYSTEM WAS USED WITH NFLEX . THE NFLEX SYSTEM IS COMPATIBLE WITH PEDICLE SCREW SYSTEMS, PANGEA SYSTEM AND CLICK¿X SYSTEM. NOTE THAT PEDICLE SCREWS AND LOCKING CAPS WERE USED WITH THE NFLEX SYSTEM. IT IS UNKNOWN IF PANGEA OR CLICK¿X WERE USED. ORIGINALLY REPORTED: THIS REPORT IS FOR AN UNKNOWN QUANTITY OF A PANGEA LOCKING CAP WITH AN UNKNOWN PART AND LOT NUMBER. REVISED: THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN LOCKING CAPS WITH AN UNKNOWN PART AND LOT NUMBER. NFLEX IS NOT CURRENTLY AVAILABLE FOR THE US MARKET; HOWEVER, IT IS AVAILABLE IN THE OUS MARKET. THE NFLEX STABILIZATION SYSTEM IS INTENDED FOR USE WITH PEDICLE SCREW FIXATION IN SKELETALLY MATURE PATIENTS TO PROVIDE CONTROLLED DYNAMIC STABILIZATION OF THE LUMBOSACRAL SPINE. SIMILAR STABILIZATION SYSTEMS ARE AVAILABLE IN THE US MARKET THUS THIS COMPLAINT IS BEING REPORTED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
NFLEX IS NOT CURRENTLY AVAILABLE FOR THE US MARKET; HOWEVER, IT IS AVAILABLE IN THE OUS MARKET. THE NFLEX STABILIZATION SYSTEM IS INTENDED FOR USE WITH PEDICLE SCREW FIXATION IN SKELETALLY MATURE PATIENTS TO PROVIDE CONTROLLED DYNAMIC STABILIZATION OF THE LUMBOSACRAL SPINE. SIMILAR STABILIZATION SYSTEMS ARE AVAILABLE IN THE US MARKET THUS THIS COMPLAINT IS BEING REPORTED. THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE BY JEFFREY D. COE, MD ET AL: NFLEX DYNAMIC STABILIZATION SYSTEM: TWO-YEAR CLINICAL OUTCOMES OF MULTI-CENTER STUDY PUBLISHED IN THE JOURNAL OF KOREAN NEUROSURGICAL SOCIETY 51: 343-349, 2012. THIS WAS A RETROSPECTIVE STUDY OF 72 CONSECUTIVE PATIENTS, FROM 5 SITES, WHO UNDERWENT NFLEX STABILIZATION, BETWEEN SEPTEMBER 2006 AND JULY 2007, AT ONE LEVEL WITH OR WITHOUT RIGID FUSION AT A CONTINUOUS LEVEL. OF THESE 72 PATIENTS, 65 WERE AVAILABLE FOR 2-YEAR FOLLOW-UP. STUDY GROUP: 65 PATIENTS (MEN = 26, WOMEN = 39); MEAN AGE OF 54.5 YEARS RANGING FROM 19-86; MEAN FOLLOW-UP WAS 25.6 MONTHS, RANGING 23-24 MONTHS. INCLUSION CRITERIA: PATIENTS WERE INCLUDED BASED ON THE PRESENCE OF DEGENERATIVE DISC DISEASE (N = 29), DEGENERATIVE SPONDYLOLISTHESIS (N = 16), LUMBAR STENOSIS (N = 9), ADJACENT SEGMENT DEGENERATION (N = 6), AND DEGENERATIVE LUMBAR SCOLIOSIS (N = 5). PREOPERATIVE IMAGING STUDIES: X-RAYS AND IN MOST CASES, COMPUTED TOMOGRAPHY AND MAGNETIC RESONANCE IMAGING (MRI). FOLLOW-UP EVALUATIONS: 3 AND 6 WEEKS (ONE CENTER ASSESSED PATIENTS AT 4 WEEKS), 3 MONTHS, 6 MONTHS, 12 AND 24 MONTHS; SOME WERE CONDUCTED THROUGH. IN SOME CASES, FOLLOW-UP EVALUATIONS WERE CONDUCTED THROUGH PHONE INTERVIEWS. RADIOGRAPHIC ASSESSMENTS INCLUDED EVIDENCE OF INSTRUMENTATION FAILURE OR SCREW LOOSENING. IMPLANT DETAILS: SINGLE DYNAMIC LEVEL (NON-FUSION) (N = ALL); TWO SINGLE-LEVEL DYNAMIC CONSTRUCTS AT NON-CONTIGUOUS LEVELS (L3-L4 AND L5-S1 (N = 2); INSTRUMENTED RIGID FUSION PERFORMED AT CONTIGUOUS LEVELS (SO CALLED ¿HYBRID FUSION¿) (N = 40); NON-FUSION DYNAMIC STABILIZATION WITHOUT FUSION SEGMENTS (N = 25); TWO-LEVEL RIGID FUSION COMBINED WITH ONE LEVEL DYNAMIC STABILIZATION AND (N = 8)3-LEVEL RIGID FUSION PLUS ONE LEVEL DYNAMIC STABILIZATION.(N = 4). DYNAMIC STABILIZATION WAS USED AT THE CONTIGUOUS SUPERIOR LEVEL IN PATIENTS (N = 33) RECEIVING THE ¿HYBRID¿ FUSION, AND WAS PLACED AT THE INFERIOR END OF THE FUSED SEGMENT(S) IN 7 (18%) OF PATIENTS RECEIVING THE HYBRID FUSION. THE MOST COMMON PATHOLOGY WAS FOR DDD AT 1 OR 2 LEVELS. NOTE THAT PANGEA SCREWS AND LOCKING CAPS WERE USED WITH THE NFLEX SYSTEM. THIS IS REPORT 3 OF 9 FOR (B)(4) FOR A PANGEA LOCKING CAP FOR THE FOLLOWING EVENTS: LUPUS PATIENT WITH DEVICE REMOVAL DUE TO INFECTION (1); ONE WITH ADJACENT LEVEL SURGERY (1).A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.
THE NFLEX SYSTEM IS COMPATIBLE WITH PEDICLE SCREW SYSTEMS, PANGEA SYSTEM AND CLICK'X SYSTEM. NOTE THAT PEDICLE SCREWS AND LOCKING CAPS WERE USED WITH THE NFLEX SYSTEM. IT IS UNKNOWN IF PANGEA OR CLICK'X WERE USED. THIS IS REPORT 3 OF 9 FOR (B)(4) FOR A PANGEA LOCKING CAP FOR THE FOLLOWING EVENTS: LUPUS PATIENT WITH DEVICE REMOVAL DUE TO INFECTION ; ONE WITH ADJACENT LEVEL SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 448006 | ORTHOSIS, SPINAL PEDICLE | NKB | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |