FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P
Report
- Report Number
- 1030489-2020-00408
- Event Type
- Injury
- Date Received
- April 2, 2020
- Date of Event
- November 20, 2019
- Report Date
- April 15, 2025
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC.
- Product Code
- NEK
- PMA / PMN Number
- SEE H10
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
B5. DESC EVT PROBLEM UPDATED. 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.
PATIENT DEMOGRAPHICS: GENDER- MALE, AGE ( AT THE TIME OF EVENT)- 51 YEARS, WEIGHT ( IN KGS) -100, WEIGHT ( IN LBS)-220, PATIENT CLINICAL ID- (B)(6), PATIENT RACE- WHITE, PATIENT ETHNICITY- NOT HISPANIC OR LATINO PRE-OPERATIVE DIAGNOSIS- INSTABILITY UP TO AND INCLUDING GRADE 2 SPONDYLOLISTHESIS, RETROLISTHESIS OR LATERAL LISTHESIS SURGERY 1: DATE OF SURGERY: (B)(6)1999 TYPE OF SPINAL SURGERY: LAMINOTOMY/FENESTRATION LEVEL(S): L5/S1 DETAILS: NO OTHER INFO AVAILABLE SURGERY 2: DATE OF SURGERY: (B)(6)2011 TYPE OF SPINAL SURGERY: LAMINOTOMY/FENESTRATION LEVEL(S): L5/S1 DETAILS: REMOVED SCAR TISSUE LEVELS IMPLANTED: L2- S1 DATE OF IMPLANT: (B)(6) 2019 TREATMENT GROUP: GROUP 1 - INFUSE 4.2 + MASTERGRAFT + LOCAL BONE INTERVENTION (ACTION SUBTYPE): EMERGENCY ROOM VISIT, DRUG THERAPY, FOLLOW UP WITH NEUROSURGERY AS SCHEDULED DIAGNOSTIC TESTS PERFORMED ON (B)(6) 2019: (1) POSTERIAL FLUID COLLECTION & EPIDURAL VENOUS DISTENTION RESULTING IN INCREASED EFFACEMENT OF THE THECAL SAC AT L4-L5 & L5-S1 WITH CROWDING OF THE CAUDA EQUINA. (2) MRI- L-SPINE-5. ONSET DATE: 16 NOV 2019 ACTION DATE: (B)(6) 2019 OUTCOME STATUS: PENDING IT WAS REPORTED THAT POST-OP, THE PATIENT EXPERIENCED SEVERE BACK PAIN AND LEFT LEG PAIN 4 DAYS POST-OP SURGERY. FOLLOW UP VISITS: DATE- (B)(6) 2020 SITE RELATED ASSESSMENT- INTERBODY FUSION: NOT RELATED PLF GRAFTING MATERIAL: NOT RELATED POSTERIOR FIXATION: NOT RELATED SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE: NOT RELATED SURGICAL PROCEDURE: NOT RELATED SPONSER RELATED ASSESSMENT- INFUSE KIT: POSSIBLE INTERBODY DEVICE: NOT RELATED MGS KIT: POSSIBLE MULTIAXIAL SCREWS: NOT RELATED PROCEDURE: POSSIBLE RODS: NOT RELATED SET SCREWS: NOT RELATED SURGICAL PROCEDURE: POSSIBLE UPDATE RECEIVED ON (B)(6) 2020: SITE RELATED ASSESSMENT- SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE: RELATED SURGICAL PROCEDURE: POSSIBLE (B)(6)2025, UPDATE RECEIVED POSSIBLE RELATED TO THE PROCEDURE ONLY BY SPONSOR.
PATIENT DEMOGRAPHICS: GENDER- MALE, AGE ( AT THE TIME OF EVENT)- 51 YEARS, WEIGHT ( IN KGS) -100, WEIGHT ( IN LBS)-220, PATIENT CLINICAL ID- (B)(6), PATIENT RACE- WHITE, PATIENT ETHNICITY- NOT HISPANIC OR LATINO PRE-OPERATIVE DIAGNOSIS- INSTABILITY UP TO AND INCLUDING GRADE 2 SPONDYLOLISTHESIS, RETROLISTHESIS OR LATERAL LISTHESIS SURGERY 1: DATE OF SURGERY: (B)(6) 1999 TYPE OF SPINAL SURGERY: LAMINOTOMY/FENESTRATION LEVEL(S): L5/S1 DETAILS: NO OTHER INFO AVAILABLE SURGERY 2: DATE OF SURGERY: (B)(6) 2011 TYPE OF SPINAL SURGERY: LAMINOTOMY/FENESTRATION LEVEL(S): L5/S1 DETAILS: REMOVED SCAR TISSUE LEVELS IMPLANTED: L2- S1 DATE OF IMPLANT: (B)(6) 2019 TREATMENT GROUP: GROUP 1 - INFUSE 4.2 + MASTERGRAFT + LOCAL BONE INTERVENTION (ACTION SUBTYPE): EMERGENCY ROOM VISIT, DRUG THERAPY, FOLLOW UP WITH NEUROSURGERY AS SCHEDULED DIAGNOSTIC TESTS PERFORMED ON (B)(6) 2019: (1)POSTERIAL FLUID COLLECTION & EPIDURAL VENOUS DISTENTION RESULTING IN INCREASED EFFACEMENT OF THE THECAL SAC AT L4-L5 & L5-S1 WITH CROWDING OF THE CAUDA EQUINA. (2) MRI- L-SPINE-5. ONSET DATE: (B)(6) 2019 ACTION DATE: (B)(6) 2019 OUTCOME STATUS: PENDING IT WAS REPORTED THAT POST-OP, THE PATIENT EXPERIENCED SEVERE BACK PAIN AND LEFT LEG PAIN 4 DAYS POST-OP SURGERY. FOLLOW UP VISITS: DATE- (B)(6) 2020 SITE RELATED ASSESSMENT- INTERBODY FUSION: NOT RELATED PLF GRAFTING MATERIAL: NOT RELATED POSTERIOR FIXATION: NOT RELATED SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE: NOT RELATED SURGICAL PROCEDURE: NOT RELATED SPONSER RELATED ASSESSMENT- INFUSE KIT: POSSIBLE INTERBODY DEVICE: NOT RELATED MGS KIT: POSSIBLE MULTIAXIAL SCREWS: NOT RELATED PROCEDURE: POSSIBLE RODS: NOT RELATED SET SCREWS: NOT RELATED SURGICAL PROCEDURE: POSSIBLE UPDATE RECEIVED ON (B)(6) 2020: SITE RELATED ASSESSMENT- SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE: RELATED SURGICAL PROCEDURE: POSSIBLE (B)(6) 2025, UPDATE RECEIVED POSSIBLE RELATED TO THE PROCEDURE ONLY BY SPONSOR. (B)(6) 2025, UPDATE RECEIVED CEC ASSESSMENT: CAUSAL RELATED TO THE PROCEDURE AND NOT RELATED TO ANY DEVICE.
THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: PRODUCT ID: 7510200, LOT#: M111814AAH, QTY.: 1, PMA: P000054, UDI: (B)(4). PRODUCT ID: 55840007550, LOT#: H5537669, QTY.: 1, 510(K): K113174, UDI: (B)(4). PRODUCT ID: 55840007545, LOT#: H5502028, QTY.: 1, 510(K): K113174, UDI: (B)(4). PRODUCT ID: 55840007545, LOT#: H5560411, QTY.: 1, 510(K): K113174, UDI: (B)(4). PRODUCT ID: 55840007545, LOT#: H5498604, QTY.: 1, 510(K): K113174, UDI: (B)(4). PRODUCT ID: 55840007545, LOT#: H5558356, QTY.: 1, 510(K): K113174, UDI: (B)(4). PRODUCT ID: 5540030, QTY.: 4, 510(K): K113174, UDI: (B)(4). PRODUCT ID: 56351310, LOT#: CA18K043, QTY.: 1, 510(K): K171689, UDI: (B)(4). PRODUCT ID: 56351310, LOT#: CA19A042, QTY.: 1, 510(K): K171689, UDI: (B)(4). PRODUCT ID: 7800320, LOT#: CCCN19H7, QTY.: 2, 510(K): K082166, UDI: (B)(4). PRODUCT ID: 1555501070, LOT#: 0720330W, QTY.: 1, 510(K): K113174, UDI: (B)(4). PRODUCT ID: 5540030, QTY.: 1, 510(K): K113174, UDI: (B)(4). PRODUCT ID: 5540030, LOT#: H5558968, QTY.: 1, 510(K): K113174, UDI: (B)(4). PRODUCT ID: 1555501070, LOT#: 0711774W, QTY.: 1, 510(K): K113174, UDI: (B)(4). PRODUCT ID: 55840007550, LOT#: H5537673, QTY.: 1, 510(K): K113174, UDI: (B)(4). ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED AS PER CLINICAL STUDY THAT THE PATIENT PRESENTED WITH SPONDYLOLISTHESIS, RETROLISTHESIS OR LATERAL LISTHESIS WITH DOCUMENTED PRE-OPERATIVE INSTABILITY AT 3 LEVELS. ON (B)(6) 2019, THE PATIENT UNDERWENT SPINAL SURGERY AT L2-S1. RODS, SCREWS, RHBMP-2/ACS, GRAFTS WERE IMPLANTED IN THE PATIENT DURING THIS SURGERY. WITH AN ONSET DATE OF (B)(6) 2019, PATIENT EXPERIENCED SEVERE BACK PAIN AND LEFT LEG PAIN 4 DAYS POST-OP SURGERY. EMERGENCY ROOM VISIT, DRUG THERAPY, FOLLOW UP WITH NEUROSURGERY AS SCHEDULED WERE ALSO PERFORMED AS A PART OF INTERVENTION FOR THIS ADVERSE EVENT. THE INVESTIGATOR NOTED THE ADVERSE EVENT AS NON-SERIOUS. SITE RELATED ASSESSMENT NOTED THAT THE ADVERSE EVENT WAS NOT RELATED TO INTERBODY FUSION, GRAFTING MATERIAL, POSTERIOR FIXATION; POSSIBLY RELATED TO SURGICAL PROCEDURE; AND RELATED TO SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE. HOWEVER, ACCORDING TO SPONSOR ASSESSMENT, THE ADVERSE EVENT WAS POSSIBLY RELATED TO RHBMP-2/ACS, GRAFTING KIT, PROCEDURE AND SURGICAL PROCEDURE. DIAGNOSTIC TESTS PERFORMED ON (B)(6) 2019: (1) POSTERIAL FLUID COLLECTION <(>&<)> EPIDURAL VENOUS DISTENTION RESULTING IN INCREASED EFFACEMENT OF THE THECAL SAC AT L4-L5 <(>&<)> L5-S1 WITH CROWDING OF THE CAUDA EQUINA. (2) MRI- L-SPINE-5., WHICH SHOWED NORMAL RESULTS. THE OUTCOME OF THIS ADVERSE EVENT IS PENDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 378690 | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC P | NEK | MEDTRONIC SOFAMOR DANEK USA, INC. | NA | SEE H10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Male | Required Intervention |