UNKNOWN_SPINE_PRODUCT
Report
- Report Number
- 0009617544-2024-00053
- Event Type
- Injury
- Date Received
- April 24, 2024
- Date of Event
- August 1, 2015
- Report Date
- August 22, 2024
- Manufacturer
- STRYKER SPINE-US
- Product Code
- NKB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H6 CODING HAS BEEN UPDATED TO REFLECT COMPLETION OF THE INVESTIGATION.
H3 OTHER TEXT: DEVICE LOCATION UNKNOWN.
THE ARTICLE 'THE ACCURACY AND SAFETY OF FLUOROSCOPICALLY GUIDED PERCUTANEOUS PEDICLE SCREWS IN THE LUMBOSACRAL JUNCTION AND THE LUMBAR SPINE' IN THE BONE AND JOINT JOURNAL 2015; 97-B:1111¿17, WAS REVIEWED. THIS WAS A RETROSPECTIVE EVALUATION STUDY UNDERTAKEN IN TWO STUDY POPULATIONS INVOLVING 203 PATIENTS (MEAN AGE 58.8 YEARS; 16 TO 91, 103 MALE, 100 FEMALE) AND 880 LUMBOSACRAL JUNCTION AND LUMBAR PERCUTANEOUS PEDICLE SCREWS. SURGERIES WERE PERFORMED BETWEEN JANUARY 2008 AND DECEMBER 2012 IN CONSECUTIVE PATIENTS. MANTIS SYSTEMS WERE USED IN ALL CASES. SCREWS WITH PERFORATIONS WERE CLASSIFIED INTO TWO TYPES. FOR MEDIAL, LATERAL, SUPERIOR AND INFERIOR PERFORATIONS, THE PEDICLE PERFORATIONS WERE ASSESSED USING GERTZBEIN AND ROBBIN¿S CLASSIFICATION AS MODIFIED BY RAO. FOR ANTERIOR PERFORATIONS, THE PEDICLE PERFORATIONS WERE ASSESSED USING A MODIFIED GRADING SYSTEM. GRADE 2 PERFORATIONS WERE CONSIDERED TO HAVE POSSIBLE COMPLICATIONS AND GRADE 3 WERE CONSIDERED CRITICAL PERFORATIONS WITH A HIGH RISK OF EARLY OR LATE COMPLICATIONS. THERE WERE A TOTAL OF 48 LATERAL PERFORATIONS, 22 ANTERIOR PERFORATIONS, 11 MEDIAL PERFORATIONS, 4 SUPERIOR PERFORATIONS AND 2 INFERIOR PERFORATIONS. ONE PATIENT (F, 71 YEARS OLD) WAS DIAGNOSED WITH METASTATIC SPINE DISEASE WITH L2 AND L3 PATHOLOGICAL FRACTURES CAUSING CAUDA EQUINE SYNDROME. A MIST WITH LAMINECTOMY AT L2 WAS PERFORMED. THE RIGHT L5 PEDICLE SCREW SHOWED GRADE 3 ANTERIOR PERFORATION ON THE POST-OPERATIVE CT SCANS. THE PATIENT HAD NO COMPLICATIONS FROM THE PERFORATION.
THE ARTICLE 'THE ACCURACY AND SAFETY OF FLUOROSCOPICALLY GUIDED PERCUTANEOUS PEDICLE SCREWS IN THE LUMBOSACRAL JUNCTION AND THE LUMBAR SPINE' IN THE BONE AND JOINT JOURNAL 2015; 97-B:1111¿17, WAS REVIEWED. THIS WAS A RETROSPECTIVE EVALUATION STUDY UNDERTAKEN IN TWO STUDY POPULATIONS INVOLVING 203 PATIENTS (MEAN AGE 58.8 YEARS; 16 TO 91, 103 MALE, 100 FEMALE) AND 880 LUMBOSACRAL JUNCTION AND LUMBAR PERCUTANEOUS PEDICLE SCREWS. SURGERIES WERE PERFORMED BETWEEN JANUARY 2008 AND DECEMBER 2012 IN CONSECUTIVE PATIENTS. MANTIS SYSTEMS WERE USED IN ALL CASES. SCREWS WITH PERFORATIONS WERE CLASSIFIED INTO TWO TYPES. FOR MEDIAL, LATERAL, SUPERIOR AND INFERIOR PERFORATIONS, THE PEDICLE PERFORATIONS WERE ASSESSED USING GERTZBEIN AND ROBBIN¿S CLASSIFICATION AS MODIFIED BY RAO. FOR ANTERIOR PERFORATIONS, THE PEDICLE PERFORATIONS WERE ASSESSED USING A MODIFIED GRADING SYSTEM. GRADE 2 PERFORATIONS WERE CONSIDERED TO HAVE POSSIBLE COMPLICATIONS AND GRADE 3 WERE CONSIDERED CRITICAL PERFORATIONS WITH A HIGH RISK OF EARLY OR LATE COMPLICATIONS. THERE WERE A TOTAL OF 48 LATERAL PERFORATIONS, 22 ANTERIOR PERFORATIONS, 11 MEDIAL PERFORATIONS, 4 SUPERIOR PERFORATIONS AND 2 INFERIOR PERFORATIONS. ONE PATIENT (F, 71 YEARS OLD) WAS DIAGNOSED WITH METASTATIC SPINE DISEASE WITH L2 AND L3 PATHOLOGICAL FRACTURES CAUSING CAUDA EQUINE SYNDROME. A MIST WITH LAMINECTOMY AT L2 WAS PERFORMED. THE RIGHT L5 PEDICLE SCREW SHOWED GRADE 3 ANTERIOR PERFORATION ON THE POST-OPERATIVE CT SCANS. THE PATIENT HAD NO COMPLICATIONS FROM THE PERFORATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 854986 | UNKNOWN_SPINE_PRODUCT | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM | NKB | STRYKER SPINE-US | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female | Other |