INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2013-01777
- Event Type
- Injury
- Date Received
- May 21, 2013
- Report Date
- November 1, 2016
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
Narratives
(B)(6). (B)(4). 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. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.
(B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
(B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES FOLLOWING THE USE OF RHBMP-2/ACS IN AN UNSPECIFIED SPINAL FUSION SURGERY. NO ADDITIONAL INFORMATION WAS REPORTED.
IT WAS REPORTED THAT ON: (B)(6) 2009: THE PATIENT WAS ADMITTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: SEVERE LOW BACK PAIN WITH DEGENERATIVE DISK L4-L5, L5-S1. SHE UNDERWENT THE FOLLOWING PROCEDURE: ANTERIOR LUMBAR INTERBODY FUSION AT L4-L5, L5-S1. PER-OP NOTES: L5-S1 DISK SPACE WAS APPROACHED, CURETTE WAS USED AND AN 11MM SPACER WAS TRIED WHICH SEEMED TO FIT WELL, SO AN 11MM PEEK SPACER WAS TAKEN AND PACKED WITH STRUCTURAL ALLOGRAFT FROM L5 VERTEBRAL BODY TAPPING IT IN PLACE AND THEN PLACING THE PLATE AND SCREWS. BEFORE PLACING PEEK SPACER, A 15MM PLUG FROM L5 VERTEBRAL BODY FILLING THIS WITH A TRICALCIUM PHOSPHATE VERTEFILL PLUG. SIMILAR PROCEDURE PERFORMED AT L4-5. THERE, A 13MM SPACER SEEMED TO FIT WELL AND THEN A PEEK SPACER WITH REMAINDER OF THE STRUCTURAL ALLOGRAFT FROM THE L5 BODY ALONG WITH BMP WAS PLACED AND TAPPED INTO PLACE. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT UNDERWENT RAD LUMBAR SPINE. IMPRESSION: POSTOPERATIVE CHANGE OF THE LOWER LUMBAR SPINE. A 54 SECONDS FLUOROSCOPY TIME UTILIZED. (B)(6) 2009: THE PATIENT WAS DISCHARGED. (B)(6) 2009: PATIENT UNDERWENT MRI OF LUMBAR SPINE. IMPRESSION: NO NEW SURGERY; SIX LUMBAR TYPE VERTEBRAE. (B)(6) 2009: PATIENT PRESENTED FOR OFFICE VISIT WITH BACK AND BILATERAL LEG PAIN. PATIENT UNDERWENT PREOPERATIVE MRI SCAN. THE MRI SCAN REFERENCES L4-5, L5-S1 BULGING DISCOPATHY WITH HYPERTROPHIED FACET AND POSSIBLE IMPINGEMENT OF BILATERAL NERVE ROOTS. IMPRESSION: L4-, L5-S1 DISCOPATHY WITH DISCOGENIC BACK PAIN. NOCICEPTIVE FACETOGENIC BACK PAIN. PATIENT WAS GIVEN EPIDURAL STEROID INJECTION. ON (B)(6) 2010: PATIENT PRESENTED FOR OFFICE VISIT WITH PAIN IN BACK AND LEFT LEG AND LEFT HIP BURSITIS. ON (B)(6) 2010: PATIENT UNDERWENT X-RAY LUMBAR SPINE. IMPRESSION: CHRONIC AND DEGENERATIVE CHANGES, TRANSITIONAL THORACOLUMBAR SEGMENT AND POSTOP CHANGES OF FUSION L4 THROUGH S1 IS EVIDENT. ON (B)(6) 2010: PATIENT PRESENTED FOR OFFICE VISIT WITH PAIN. ON (B)(6) 2010: PATIENT UNDERWENT CT LUMBAR SPINE WITHOUT CONTRAST. IMPRESSION: THERE IS LOSS OF HEIGHT OF L5 VERTEBRAL BODY, WHEN COMPARED TO POST OPERATIVE FLUOROSCOPIC IMAGES OF (B)(6) 2009. NO EVIDENCE OF SUBLUXATION OR FRACTURE OF ANY OF METALLIC HARDWARE OR DISLODGEMENT OF THE EITHER OF THE FUSION DEVICES AT L4-5 OR L5-S1 DISKS. PATIENT ALSO UNDERWENT MRI LUMBAR SPINE. IMPRESSION: POSTOPERATIVE LUMBAR SPINE WITH ANTERIOR FUSION AT L4-5 AND L5-S1 WITH DISC INTERVENTIONS AT THESE LEVELS. MILD BROAD BASED DISC BULGING AT L4-5. NO SIGNIFICANT CENTRAL CANAL OR FORAMINAL STENOSIS NOTED AT ANY LUMBAR LEVEL. ON (B)(6) 2010: PATIENT PRESENTED FOR OFFICE VISIT WITH PAIN. PATIENT UNDERWENT MR SCAN OF LUMBAR SPINE. IMPRESSION: NOTHING PUSHING THE NERVES CAN BE SEEN, NO SIGNIFICANT SPINAL STENOSIS OR FORAMINAL STENOSIS OR HERNIATED DISCS. PATIENT ALSO UNDERWENT CT SCAN OF LUMBAR SPINE. IMPRESSION: HARDWARE IS IN GOOD POSITION. BRIDGING BONE CAN BE SEEN IN PART OF DISC SPACE. (B)(6) 2010: PATIENT UNDERWENT MRI CERVICAL SPINE. IMPRESSION: STATUS POST SURGICAL CHANGE SINCE THE PREVIOUS EXAM ON (B)(6) 2007. SMALL ARACHNOID CYST IN THE RIGHT TEMPORAL FOSSA. PATIENT ALSO UNDERWENT MRI LUMBAR SPINE. IMPRESSION: NEW SURGICAL CHANGE WITH AN ANTERIOR PLATE AT L4, L5 AND S1. THERE ARE ALSO SPACERS AT L4-L5 AND L5-S1. THERE ARE TWO CANCELLOUS SCREWS THROUGH THE VERTEBRAL BODIES OF L4, L5 AND S1. MINIMAL BROAD BASED DISC BULGE AT L4-5 RESULTING IN QUESTIONABLE NERVE IMPINGEMENT. BROAD BASED DISC BULGE AT L5-S1 RESULTING IN BILATERAL NERVE IMPINGEMENT. ON (B)(6) 2010: PATIENT PRESENTED FOR OFFICE VISIT WITH NECK PAIN AND LOW BACK PAIN. ON (B)(6) 2011: PATIENT UNDERWENT THREE VIEWS OF LUMBAR SPINE WITH FLEXION AND EXTENSION. IMPRESSION: NO SPONDYLOLISTHESIS. AREA OF FUSION IS IMMOBILE. STATUS POST SURGICAL CHANGES. NO INCREASED SPONDYLOLISTHESIS WITH FLEXION AND EXTENSION. ON (B)(6) 2011: PATIENT UNDERWENT CT LUMBAR SPINE DUE TO PAIN. IMPRESSION: ANTERIOR FUSION HARDWARE EXTENDS FROM L4 THROUGH S1 WITH INTERBODY SPACERS L4-5 AND L5-S1. SPACERS PRODUCE SOME EROSIVE CHANGE OF L5 INTERVERTEBRAL BODY WITH PARTIAL COLLAPSE OF L5 BODY. THIS MAY BE CHRONIC AND PRESENT PRIOR TO SURGICAL INTERVENTION. MILD TO MODERATE DEGENERATIVE CHANGES ARE PRESENT FROM L3-4 TO THROUGH THE L5-S1 LEVEL. CENTRAL CANAL REMAINS PATENT AT ALL LEVELS. DIVERTICULOSIS IS PRESENT WITHOUT EVIDENCE OF ACUTE DIVERTICULITIS. ON (B)(6) 2011: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2011: PATIENT PRESENTED FOR OFFICE VISIT WITH LOW BACK PAIN, NECK PAIN AND SOME INTRASCAPULAR PAIN. ON (B)(6) 2011: THE PATIENT PRESENTED WITH THE FOLLOWING PRE-OP DIAGNOSIS: PSEUDOARTHROSIS L5-S1. SHE HAD THE FOLLOWING POST-OP DIAGNOSIS: PSEUDOARTHROSIS L4-L5, L5-S1. SHE UNDERWENT THE FOLLOWING PROCEDURES: BILATERAL LAMINECTOMY, L4-5, L5-S1; PEDICLE SCREWS AT L4, L5, S1; POSTEROLATERAL FUSION, L4-5, S1. PATHOLOGICAL FINDINGS: THERE IS SOME MILD TO MODERATE SPINAL STENOSIS WITH SOME ENLARGED FACETS.
IT WAS REPORTED THAT ON (B)(6) 2009: THE PATIENT UNDERWENT DIGITAL MAMMOGRAPHY BILATERALLY. IMPRESSION: RESOLUTION OF PREVIOUSLY NOTED ASYMMETRIC DENSITY CENTRAL PORTION OF THE LEFT BREAST.
IT WAS REPORTED THAT ON (B)(6) 2009: ON A TELEPHONIC CONVERSATION, PATIENT STATED THAT SHE WAS STILL HAVING PAIN IN BACK AND LEG. ON (B)(6) 2009: THE PATIENT UNDERWENT DIGITAL MAMMOGRAPHY BILATERALLY. IMPRESSION: RESOLUTION OF PREVIOUSLY NOTED ASYMMETRIC DENSITY CENTRAL PORTION OF THE LEFT BREAST. ON (B)(6) 2010: PATIENT UNDERWENT LEFT AND RIGHT L3, L4 AND L5 MEDIAL BRANCH NERVE BLOCK; FLUOROSCOPY FOR NEEDLE GUIDANCE CONFIRMATION OF PLACEMENT; MODERATE IV SEDATION. DIAGNOSES: MECHANICAL LOW BACK PAIN CONSISTENT WITH FACET SYNDROME, ISOLATED TO THE POSTERIOR COMPARTMENT OF THE LOWER LUMBAR SPINE, STATUS POST ANTERIOR COMPARTMENT FUSION. MODERATE ANXIETY OVER A PAINFUL PROCEDURE, REQUESTING INTRAVENOUS SEDATION. ON (B)(6) 2010: THE PATIENT UNDERWENT LEFT L2, L3, L4 AND L5 MEDIAL BRANCH NERVE RADIOFREQUENCY ABLATION. FLUOROSCOPIC NEEDLE GUIDANCE CONFIRMATION PLACEMENT. IV SEDATION PER PATIENT'S REQUESTS. ON (B)(6) 2011, THE PATIENT PRESENTED FOR CHEST X-RAY. IMPRESSION; NO ACUTE INTRATHORACIC PROCESS. ON (B)(6) 2011: THE PATIENT PRESENTED WITH LOW BACK PAIN.
IT WAS REPORTED THAT ON: (B)(6) 2009: PATIENT PRESENTED WITH COMPLAINT OF BACK PAIN AND ANEMIA. ASSESSMENT: ANEMIA NEC; LUMBAGO. ON (B)(6) 2009: PATIENT PRESENTED WITH COMPLAINT OF BACK PAIN. ASSESSMENT: LUMBOSACRAL DISC DEGENERATION. ON (B)(6) 2009: PATIENT PRESENTED WITH ¿UTI¿. ASSESSMENT: MIXED INCONTINENCE; LUMBAGO. ON (B)(6) 2009: PATIENT PRESENTED WITH COMPLAINT OF BACK PAIN AND HAD H1N1 SHOT. ASSESSMENT: LUMBAGO. ON (B)(6) 2009: PATIENT PRESENTED WITH COMPLAINT OF SKIN LESION IN UMBILICAL AREA, BACK PAIN AND ¿GERD¿. IMPRESSION: LUMBAGO; DEPRESSIVE DISORDER; OBESITY; DERMATOPHYTOSIS OF BODY; ESOPHAGEAL REFLUX. ON (B)(6) 2009: PATIENT PRESENTED WITH FOR MOLE REMOVAL, COMPLAINT OF BACK PAIN AND HYPERTENSION. ASSESSMENT: BENIGN HYPERTENSION; NEVUS, NON-NEOPLASTIC; LUMBAGO. ON (B)(6) 2010: PATIENT PRESENTED WITH COMPLAINT OF MOUTH SORE AND COLD SYMPTOMS. ASSESSMENT: ACUTE SINUSITIS; THRUSH. ON (B)(6) 2010: PATIENT PRESENTED WITH COMPLAINT OF SKIN LESION ON LEFT SHOULDER AND BACK PAIN. IMPRESSION: NEVUS, NON-NEOPLASTIC; LUMBAGO. ON (B)(6) 2010: PATIENT PRESENTED WITH COMPLAINT OF HYPERTENSION, BACK PAIN AND ALLERGIES. ASSESSMENT: BENIGN HYPERTENSION; LUMBAGO; ALLERGIC RHINITIS. ON (B)(6) 2010: PATIENT PRESENTED WITH COMPLAINT OF ANEMIA AND SEVERE BACK PAIN. ASSESSMENT: ANEMIA; LUMBAGO; CERVICALGIA; OBESITY. ON (B)(6) 2010: PATIENT PRESENTED WITH COMPLAINT OF HYPERTENSION AND BACK PAIN. ASSESSMENT: BENIGN HYPERTENSION; LUMBAGO. ON (B)(6) 2010: PATIENT PRESENTED WITH COMPLAINT OF EXCESSIVE MENSES. ASSESSMENT: EXCESSIVE MENSTRUATION. ON (B)(6) 2010: PATIENT PRESENTED WITH COMPLAINT OF BACK PAIN, ¿GERD¿. IMPRESSION: LUMBAGO; ESOPHAGEAL REFLUX. ON (B)(6) 2010: PATIENT PRESENTED WITH COMPLAINT OF BACK PAIN, ALLERGIES, HYPERTENSION. ASSESSMENT: LUMBAGO; ALLERGIC RHINITIS; BENIGN HYPERTENSION. ON (B)(6) 2010: PATIENT PRESENTED WITH COMPLAINT OF BACK PAIN AND SORE THROAT. ASSESSMENT: CERVICALGIA; LUMBAGO; ACUTE PHARYNGITIS. ON (B)(6) 2010: PATIENT PRESENTED WITH COMPLAINT OF DEPRESSION, BACK PAIN, EDEMA AND MENOPAUSAL SYMPTOMS. ASSESSMENT: DEPRESSIVE DISORDER; SPINAL STENOSIS- LUMBAR; LOCAL SKIN INFECTION; EDEMA AND MENOPAUSAL DISORDER. ON (B)(6) 2010, (B)(6) 2011: PATIENT PRESENTED WITH COMPLAINT OF SORE THROAT. ASSESSMENT: ACUTE PHARYNGITIS; BENIGN HYPERTENSION. ON (B)(6) 2011: PATIENT PRESENTED WITH COMPLAINT OF BACK PAIN. ASSESSMENT: URINARY TRACT INFECTION. ON (B)(6) 2011: PATIENT PRESENTED WITH ANEMIA AND DEPRESSION. ASSESSMENT: DEPRESSIVE DISORDER; ANEMIA. ON (B)(6) 2011: PATIENT PRESENTED WITH COLD SYMPTOMS AND DEPRESSION. ASSESSMENT: ACUTE SINUSITIS; DEPRESSIVE DISORDER; ANEMIA.
IT WAS REPORTED THAT ON (B)(6) 2009: PATIENT UNDERWENT LEFT LOWER EXTREMITY VENOUS DUPLEX SCAN DUE TO INDICATION OF LEFT CALF, ANKLE, AND FOOT SWELLING. IMPRESSION: NO EVIDENCE OF SUPERFICIAL OR DEEP VENOUS THROMBOSIS INVOLVING THE LEFT LOWER EXTREMITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224895 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M110803AAQ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |