INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2013-00999
- Event Type
- Injury
- Date Received
- April 11, 2013
- Report Date
- April 14, 2016
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PATIENT
Narratives
(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)(6).
(B)(4).
(B)(4).
(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).
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE USING RHBMP-2/ACS. POST-OP, THE PATIENT REPORTEDLY HAS HAD TO VISIT THE DOCTOR FREQUENTLY, HAS HAD COMPLICATIONS, PAIN, AND HAS UNDERGONE A REVISION SURGERY.
IT WAS REPORTED THAT ON (B)(6) 2008 THE PATIENT PRESENTED FOR AN OFFICE VISIT WITH CHIEF COMPLAINT OF CERVICAL SPINE PAIN AND PARESTHESIA IN THE LEFT LOWER EXTREMITY <(>&<)> BOTH UPPER EXTREMITIES. THE PATIENT UNDERWENT EMG/ NCV , WHICH SHOWED EVIDENCE OF MILD LEFT SENSORY MEDIAN COMPRESSIVE NEUROPATHY ACROSS LEFT CARPAL TUNNEL WITHOUT ANY LOSS IN SNAP AMPLITUDE.
IT WAS REPORTED THAT ON (B)(6) 2009 PATIENT ADMITTED WITH FOLLOWING ADMISSION DIAGNOSIS: ABDOMINAL PAIN GASTRITIS. ON (B)(6) 2011: PATIENT UNDERWENT X-RAY OF LUMBAR SPINE. PATIENT ADMITTED WITH FOLLOWING ADMISSION DIAGNOSIS: "BLE" PAIN AND SWELLING POST SURGERY. ON (B)(6) 2011 PATIENT ADMITTED WITH FOLLOWING ADMISSION DIAGNOSIS: PELVIC PAIN. ON (B)(6) 2012: PATIENT ADMITTED WITH FOLLOWING ADMISSION DIAGNOSIS: CERVICAL SPONDYLOSIS, LOWER EXTREMITY WEAKNESS. ON (B)(6) 2012 PATIENT ADMITTED WITH FOLLOWING ADMISSION DIAGNOSIS: PAIN AND STIFFNESS RIGHT WRIST. ON (B)(6) 2013 PATIENT ADMITTED WITH FOLLOWING ADMISSION DIAGNOSIS: LUMBOSACRAL SPONDYLOSIS. ON (B)(6) 2013 PATIENT ADMITTED WITH FOLLOWING ADMISSION DIAGNOSIS: ABDOMINAL PAIN. ON (B)(6) 2014 PATIENT ADMITTED WITH FOLLOWING ADMISSION DIAGNOSIS: DEGENERATION OF CERVICAL INTERVERTEBRAL. ON (B)(6) 2015 PATIENT ADMITTED WITH FOLLOWING ADMISSION DIAGNOSIS: LUMBAR SPONDYLOSIS.
IT WAS REPORTED THAT ON (B)(6) 2011 THE PATIENT WAS DIAGNOSED WITH LUMBOSACRAL SPONDYLOSIS. THE PATIENT UNDERWENT CT OF THE LUMBAR SPINE DUE TO LOW BACK PAIN. FINDINGS: AT THE L2-L43 , THERE IS CONTRAST PRESENT WITHIN THE CENTRAL PORTION OF THE INTERVERTEBRAL DISC WITH A SMALL AMOUNT OF CONTRAST EXTENDING FAR LATERALLY AND TO THE LEFT TO THE MARGINS OF THE END PLATES. AT THE L3-4 LEVEL, THERE WAS CONTRAST PRESENT DIFFUSELY THROUGHOUT THE INTERVERTEBRAL DISC AND CONTRAST EXTENDS TO AND BEYOND THE MARGINAL CONFINES OF THE END PLATES. NO FOCAL CONTRAST EXTENDING BEYOND THE CONFINES OF THE ENDPLATES IS EVIDENT. AT THE L4-5 LEVEL, THERE IS CONTRAST PRESENT DIFFUSELY WITH CONTRAST EXTENDING TO THE MARGINS AND BEYOND THE MARGINS OF THE END PLATES. NO DEFINITIVE FOCUS OF CONTRAST EXTENDS BEYOND THE MARGINS OF THE END PLATES. ON (B)(6) 2012 THE PATIENT PRESENTED FOR AN OFFICE VISIT. THE PATIENT WAS DIAGNOSED WITH LUMBAR SPONDYLOSIS. THE PATIENT UNDERWENT X-RAY OF THE CHEST PA AND LATERAL. NO ACUTE INFILTRATE OR PLEURAL EFFUSIONS ARE IDENTIFIED. THE SIZE OF THE CARDIAC SILHOUETTE APPEARS WITHIN NORMAL LIMITS. POST OPERATIVE CHANGES ARE EVIDENT. NO ACUTE CARDIOPULMONARY PROCESS IS IDENTIFIED.
IT WAS REPORTED THAT ON (B)(6) 2008: PATIENT REPORTED NUMBNESS STARTING IN HIS NECK AND INTO HIS SHOULDER AND ARM AND EXTEND UPTO BACK OF HIS HEAD, LEFT SIDE OF FACE AND HIS LEFT ARM, SORENESS IN NECK AND NECK MOVES WITH HURTING. SYMPTOMS WERE SIMILAR TO THOSE BEFORE NECK SURGERY SIX YEARS AGO. ASSESSMENT: NECK PAIN. NUMBNESS IN LEFT ARM AND LEG. DECREASE STRENGTH ON LEFT. THE PATIENT UNDERWENT X-RAY OF CERVICAL SPINE, WHICH SHOWED ANTERIOR COMPRESSION PLATES AT SITE OF HEALED INTERBODY FUSION AT C4-C5-C6 IN SATISFACTORY POSITION. MILD NARROWING AND SPONDYLOSIS AT THE C6-C7 DISC. THERE WAS LUCENCY ACROSS BASE OF ODONTOID ON THE OPEN MOUTH VIEW, WHICH MAY BE AN ARTIFACT. ON (B)(6) 2008 THE PATIENT WAS PRESENTED FOR OFFICE VISIT FOR MEDICAL EVALUATION. ON (B)(6) 2008 THE PATIENT UNDERWENT XRAYS OF THE CERVICAL SPINE. IMPRESSIONS: POSTOPERATIVE CHANGES ABOUT THE CERVICAL SPINE. ON (B)(6) 2008: PATIENT UNDERWENT X-RAY OF CERVICAL SPINE. IMPRESSION: ANTERIOR FUSION C3-C6, NO UNUSAL POST-OP FINISHING. SPONDYLITIC CHANGE AT C6-C7. ON (B)(6) 2008: PATIENT UNDERWENT X-RAY OF CERVICAL SPINE. IMPRESSION: STABLE C3-C6 FUSION. ON (B)(6) 2008 THE PATIENT WAS PRESENTED FOR OFFICE VISIT FOR MEDICAL EVALUATION. ASSESSMENTS: SEVERE HEADACHE, RADICULOPATHY, ANEMIA (B)(6) 2008: PATIENT UNDERWENT FLUOROSCOPIC GUIDED CERVICAL MYELOGRAM. IMPRESSION: SUCCESSFUL CERVICAL MYELOGRAM WITHOUT DEFINITIVE EVIDENCE OF NERVE ROOT TRUNCATION OR HIGH GRADE SPINAL CANAL STENOSIS. ON (B)(6) 2008: PATIENT UNDERWENT X-RAY OF CHEST. IMPRESSION: THE HEART SIZE IS NORMAL. THE LUNGS ARE CLEAR. NO EVIDENCE OF HEART FAILURE OR PLEURAL DISEASE ARE SEEN. THE OSSEOUS STRUCTURES ARE NORMAL. ON (B)(6) 2008: THE PATIENT COMPLAINED OF HNP. THE PATIENT UNDERWENT AR SPINE CERVICAL AP-LATERAL. IMPRESSION: PREVIOUS ANTERIOR FUSION AT C3-C6 IS RADIOGRAPHICALLY SOLID STABLE. INTERVAL DECOMPRESSIVE LAMINECTOMY AND POSTERIOR FUSION AT C3-C7, NO UNUSUAL POST-OP FINDINGS. ON (B)(6) 2008: PATIENT UNDERWENT X-RAY OF CERVICAL SPINE. IMPRESSION: EVIDENCE OF ANTERIOR CERVICAL C3-C6 AS WELL AS INTERVAL POSTERIOR FUSION AND DECOMPRESSIVE LAMINECTOMY C3-C7, ALL WITH STABLE STRAIGHTENING OF CERVICAL SPINE. ON (B)(6) 2008: PATIENT UNDERWENT X-RAY OF CERVICAL SPINE. IMPRESSION: STABLE ANTERIOR, POSTERIOR FUSION OF CERVICAL SPINE. STABLE CERVICAL SPINE STRAIGHTENING. ON (B)(6) 2008: THE PATIENT UNDERWENT X-RAY OF CERVICAL SPINE FOR INDICATION OF NECK PAIN. IMPRESSION: STABLE APPEARING POST FUSION CHA NGES INVOLVING THE CERVICAL SPINE WITH NO COMPLICATING PROCESS OR INTERVAL CHANGE IDENTIFIED. ON (B)(6) 2008: THE PATIENT UNDERWENT TRIAL IMPLANTATION OF OCCIPITAL NERVE STIMULATOR. ON (B)(6) 2008: THE PATIENT UNDERWENT BILATERAL IMPLANTATION OF SPINAL CORD STIMULATOR. ON (B)(6) 2008: THE PATIENT UNDERWENT CT OF HEAD. PATIENT UNDERWENT X-RAY OF CHEST. IMPRESSION: NO ACUTE CARDIOPULMONARY PATHOLOGY IS IDENTIFIED. ON (B)(6) 2008: THE PATIENT UNDERWENT CT SCAN OF NECK. IMPRESSION: BILATERAL LAMINECTOMY DEFECT C3 THROUGH C7. THERE IS ALSO ANTERIOR F USION OF C-C6. METALLIC FIXATION DEVICE ARE NOTED ANTERIORLY AND POSTERIORLY. MILD DEGENERATIVE DISC CHANGES AT C6-C7. THERE IS NO ACUTE PATHOLOGY DEMONSTRATED. INCIDENTALLY, THERE IS NOTED CENTRILOBULAR EMPHY SEMATOUS CHANGES OF BOTH UPPER LUNG FIELDS. ON (B)(6) 2008: THE PATIENT UNDERWENT CT OF HEAD. IMPRESSION: NORMAL CT OF HEAD. ON (B)(6) 2009: THE PATIENT UNDERWENT X-RAY OF SKULL. IMPRESSION: C3 THROUGH C6 ANTERIOR FUSION AND C3-C7 POSTERIOR FUSION, WITH HARDWARE AND POSTERIOR ELECTRODES. ON (B)(6) 2009 THE PATIENT PRESENTED WITH ADMITTING DIAGNOSIS OF HEADACHES. ASSESSMENT: NEUROLOGICAL EXAMINATION: THERE IS HESITANCY OF SPEECH, AND WEAKNESS, BUT NO FRANK APHASIA. IMPRESSION: FAILED OCCIPITAL STIMULATOR. THE PATIENT UNDERWENT REVISION AND REPOSITION OF LEFT OCCIPITAL NERVE STIMULATOR. THE PATIENT UNDERWENT CT HEAD W/O CONTRAST. IMPRESSION: INTERVAL PLACEMENT OF OCCIPITAL NERVE STIMULATOR LEADS HAVE BEEN PLACED WITHIN THE SUPERFICIAL SOFT TISSUE OF THE POSTERIOR UPPER NECK. NO INTRACRANIAL ABNORMALITY IS SEEN. ON (B)(6) 2009: PATIENT REPORTED BACK PAIN RADIATING INTO BOTH LEGS, WEAKNESS AND NUMBNESS IN LEGS AND DIFFICULTY IN WALKING BECAUSE OF IT. ASSESSMENT: BACK PAIN. STROKE. DDD. RADICULOPATHY. PATIENT UNDERWENT CT OF LUMBAR SPINE. IMPRESSION: NO EVIDENCE OF ACUTE PATHOLOGY IN THE LUMBAR SPINE. MILD TO MODERATE DEGENERATIVE CHANGES ARE NOTED INFERIORLY. IF THERE IS CLINICAL CONCERN FOR DISC PATHOLOGY, FURTHER EVALUATION WITH CT MYELOGRAPHY MAY BE HELPFUL. ON (B)(6) 2009: PATIENT PRESENTED FOR FOLLOW-UP. PATIENT REPORTED NUMBNESS AND WEAKNESS IN FEET. 05 FEB 2009: PATIENT PRESENTED FOR FOLLOW-UP. ASSESSMENT: NECK AND BACK PAIN. STROKE. DDD. RADICULOPATHY. ON (B)(6) 2009: PATIENT UNDERWENT X-RAY OF CERVICAL SPINE. IMPRESSION: EVIDENCE OF ANTERIOR CERVICAL FUSION FROM C3 THROUGH C6 AND D ECOMPRESSIVE LAMINECTOMIES WITH POSTERIOR FUSION FORM C3 THROUGH C7. THE ALIGNMENT REMAINS ANATOMIC. DEGENERATIVE CHANGES AT (B)(4). NO ABNORMAL LISTHESIS. ON (B)(6) 2009: PATIENT PRESENTED FOR FOLLOW-UP. PATIENT REPORTED SPELLS OF LOSING BALANCE AND SPEECH. ASSESSMENT: NECK AND BACK PAIN. STROKE. DDD. ON (B)(6) 2009: PATIENT PRESENTED FOR FOLLOW-UP. PATIENT UNDERWENT CT OF ABDOMEN AND PELVIS. IMPRESSION: NORMAL URINARY TRACT. THERE IS AN INCIDENTAL FINDING OF VERY SMALL SPLEEN MEASURING 5.6 X 1.6 CM. THE REMAINDER OF ABDOMEN AND PELVIS DEMONSTRATE NO OTHER SIGNIFICANT ABNORMALITIES. ON (B)(6) 2009, PATIENT REPORTED SPASMS IN NECK, HEADACHES AND WEAKNESS IN RIGHT HAND. ON (B)(6) 2010: PATIENT UNDERWENT X-RAY OF SKULL. IMPRESSION: STATUS POST-OP CERVICAL FUSION, NOT COMPLETELY INCLUDED IN THIS STUDY. STIMULATOR ELECTRODES WITHIN THE POSTERIOR OCCIPITAL SOFT TISSUES, WITHOUT GROSS CHANGE IN POSITION. ON (B)(6) 2010: IMPRESSION: STABLE ANTERIOR, INTERBODY FUSION C3-C6, STABLE LAMINECTOMY, POSTERIOR FUSION C3-C7. 2. MINIMAL ANTEROLISTHESIS C6-C7. SPONDYLOSIS C6/C7. ON (B)(6) 2010: THE PATIENT UNDERWENT X-RAY MYELOGRAM OF LUMBAR SPINE. ON (B)(6) 2010: THE PATIENT UNDERWENT REPLACEMENT AND REPOSITIONING OF BILATERAL OCCIPITAL NERVE STIMULATOR; RIGHT ENDOSCOPIC CARPAL TUNNEL RELEASE. ON (B)(6) 2010: THE PATIENT UNDERWENT X-RAY OF LUMBAR SPINE. IMPRESSION: MILD MULTILEVEL LUMBAR SPONDYLOSIS. ON (B)(6) 2011: THE PATIENT UNDERWENT CT OF RIGHT WRIST FOR COMPLAINTS OF WRIST PAIN. IMPRESSION: NO SIGNIFICANT ABNORMALITY OF RIGHT WRIST IS IDENTIFIED. PATIENT UNDERWENT CT OF HEAD DUE TO HEADACHE. IMPRESSION: NORMAL UNENHANCED CT APPEARANCE OF THE BRAIN AND SKULL. POST SURGICAL CHANGES.
IT WAS REPORTED THAT ON, (B)(6) 2014 THE PATIENT UNDERWENT RAD CHEST PA AND LATERAL. ON (B)(6) 2015 PATIENT PRESENTED FOR AN OFFICE VISIT DUE TO TOOTHACHE. ON (B)(6) 2015 PATIENT PRESENTED FOR AN OFFICE VISIT DUE TO DYSPNEA, RASH. ON (B)(6) 2015 PER BILLING RECORDS, PATIENT UNDERWENT CHEST X-RAY. ON (B)(6) 2015 PATIENT UNDERWENT CT HEAD WITHOUT CONTRAST.
IT WAS REPORTED THAT ON (B)(6) 2009: THE PATIENT PRESENTED WITH PRIMARY DIAGNOSIS OF TRANSIENT LEFT FACIAL PAIN, SEVERE HEAD PAIN, ARM PAIN AND HISTORY OF DEPRESSION. THE PATIENT UNDERWENT CT SCAN OF HEAD WITHOUT CONTRAST DUE TO INDICATIONS OF HEADACHE AND CEREBROVASCULAR ACCIDENT (CVA). IMPRESSION: UNREMARKABLE NONCONTRAST CT BRAIN SCANS. ON THE SAME DAY PATIENT AGAIN UNDERWENT CT SCAN OF HEAD WITHOUT CONTRAST WITH HISTORY OF HEADACHES. IMPRESSION: NORMAL EXAM. PATIENT ALSO UNDERWENT CT SCAN OF THE CERVICAL SPINE WITHOUT CONTRAST DUE TO HISTORY OF NECK PAIN. IMPRESSIONS: NO SIGNIFICANT ABNORMALITY. THE PATIENT UNDERWENT CT SCAN OF LUMBAR SPINE WHICH SHOWED DEGENERATIVE DISEASE AND LUMBAR SPONDYLOSIS. A LUMBAR MYLEOGRAM WAS DONE AND SHOWED DISC DISEASE, DEGENERATIVE DISEASE AND DISC BULGES AT L3-4, L4-5 AND L5-S1.. ROS: NEUROLOGICAL: DYSARTHRIC SPEECH. MODERATE LEFT SIDED WEAKNESS CONSISTENT WITH LEFT HEMIPARESIS. IMPRESSION: CERVICAL MYELOPATHY, HEADACHES, BACK PAIN, MOOD DISTURBANCES. ON (B)(6) 2010: THE PATIENT UNDERWENT CT MYELOGRAM OF THE LUMBAR SPINE DUE TO INDICATION OF BACK PAIN. IMPRESSION: THERE WAS TRANSITIONAL LUMBOSACRAL ANATOMY; MILD DEGENERATIVE CHANGES IN THE LOWER LUMBAR SPINE; DIFFUSE DISC BULGES. PATIENT UNDERWENT X-RAY MYELOGRAM OF LUMBAR SPINE. IMPRESSION: LUMBAR MYLEOGRAM. SMALL DISC BULGES AT L3-4, L4-5 AND L5-S1. ON (B)(6) 2010: IMPRESSION: FAILED OCCIPITAL STIMULATION. RIGHT SENSORY MEDIAN NEUROPATHY ACROSS THE RIGHT CARPAL TUNNEL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154873 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M110704AAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |