UNKNOWN
Report
- Report Number
- 1030489-2024-01210
- Event Type
- Malfunction
- Date Received
- September 30, 2024
- Report Date
- September 30, 2024
- Manufacturer
- MDT SOFAMOR DANEK PUERTO RICO MFG
- Product Code
- NKB
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 48 FEMALES AND 26 MALE PATIENTS. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PRODUCT IDENTIFIERS ARE UNKNOWN. G3: 510(K)# IS UNKNOWN. H6: NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. NATHAN R. HENDRICKSON, JASON J. HASELHUHN, KARI ODLAND, JONATHAN N. SEMBRANO, CHRISTOPHER T. MARTIN, KRISTEN E. JONES, DAVID W. POLLY CITATION: WORLD NEUROSURG. (2024) 190:172-180. HTTPS://DOI.ORG/10.1016/J.WNEU.2024.06.046 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
LITERATURE WAS REVIEWED REGARDING SACROPELVIC FIXATION WITH POROUS FUSION/FIXATION SCREWS: A TECHNICAL NOTE AND RETROSPECTIVE REVIEW. SCREWS WERE USED FOR PFFS IN SACROPELVIC FIXATION. THE USE OF PFFS RESULTED IN SIGNIFICANT IMPROVEMENTS IN PATIENT-REPORTED OUTCOMES POSTOPERATIVELY. THE STUDY REPORTED LOW RATES OF MALPOSITION, ESPECIALLY IN STACKED CONFIGURATIONS WITH COMPUTER-ASSISTED NAVIGATION. THE STUDY EXAMINED THE USE OF POROUS FUSION/FIXATION SCREWS (PFFS) FOR SACROPELVIC FIXATION IN 74 PATIENTS (26 MALES, 48 FEMALES). IMPLANT PLACEMENT ACCURACY - THE STUDY REPORTED LOW RATES OF MALPOSITION, ESPECIALLY IN STACKED CONFIGURATIONS WITH COMPUTER-ASSISTED NAVIGATION. PFFS CAN BE SAFELY USED FOR SACROPELVIC FIXATION, LEADING TO GOOD CLINICAL OUTCOMES. DEVICE MALFUNCTIONS: TOTAL PFFS USED: 235. TOTAL MALPOSITIONS: 6. CEPHALIC PFFS IN STACKED CONFIGURATION: 4 OUT OF 88. CAUDAL PFFS IN STACKED CONFIGURATION: 1 OUT OF 123. S2-ALAR-ILIAC (SAI) PFFS IN STAND-ALONE CONFIGURATION: 1 OUT OF 24. MALPOSITION LOCATIONS: 4 MEDIAL CORTICAL BREACHES. 1 LATERAL CORTICAL BREACH. 1 INFERIOR CORTICAL BREACH. NATURE OF MALPOSITIONS: ALL WERE GRADE 3 CORTICAL BREACHES (>4MM PERFORATION), REVISED INTRAOPERATIVELY WITHOUT MAJOR SEQUELA. PATIENT COMPLICATIONS: COMPLICATIONS FROM MALPOSITIONING: NO MAJOR VASCULAR OR VISCERAL INJURIES. NO ACUTE PELVIC FIXATION FAILURES WITHIN 6 WEEKS POST-SURGERY. SIGNIFICANT FINDINGS: SIGNIFICANT IMPROVEMENTS IN ODI AND VAS BACK PAIN AND PROMIS PHYSICAL HEALTH SCORES IN NON-MALPOSITION PATIENTS. CONCLUSION: THE STUDY CONCLUDED THAT ALTHOUGH PFFSS ARE LARGER THAN TRADITIONAL SACROPELVIC FIXATION SCREWS, THEY CAN BE PLACED SAFELY WITH COMPUTER-ASSISTED NAVIGATION. THE MALPOSITION RATE WAS LOW, WITH SUCCESSFUL REVISIONS INTRAOPERATIVELY, AND SIGNIFICANT IMPROVEMENTS IN PATIENT OUTCOMES POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1061097 | UNKNOWN | THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM | NKB | MDT SOFAMOR DANEK PUERTO RICO MFG | MSB_UNK_SCREW | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Unknown |