INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2013-02057
- Event Type
- Injury
- Date Received
- June 3, 2013
- Report Date
- July 10, 2013
- Manufacturer
- MEDTRONIC SOFAMOR DANEK USA, INC
- Product Code
- NEK
- PMA / PMN Number
- P000058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- ATTORNEY
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.
ADDITIONAL INFORMATION: (B)(4) - (PAIN); (NERVE DAMAGE).
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) 2011: PATIENT PRESENTED INITIALLY 3 DAYS AFTER A ROLLOVER MVA WHERE PATIENT SUFFERED A T10 BURST FRACTURE OF THE THORACIC VERTEBRAE. POST OP THE PATIENT DEVELOPED DECREASED O2 SATURATIONS. IMPRESSION: 1. POSTOP SURGICAL TREATMENT OF T10 BURST FRACTURE; 2. POST OP RESPIRATORY INSUFFICIENCY SECONDARY TO PAIN MANAGEMENT SEDATIVES AND ANALGESICS. DECREASED LUNG VOLUMES DUE TO SUPINE POSITION AND SURGERY. ON (B)(6) 2011: MRI OF THE THORACIC SPINE WAS PERFORMED. IMPRESSION: 1. COMPRESSION DEFORMITY OF ENDPLATE OF T10 AND SUPERIOR ENDPLATE OF T11; 2. EDEMA SEEN WITHIN THE INTERSPINOUS LIGAMENTS OF THE T9-T10 AND T10-T11 INTERSPACE IS CONSISTENT WITH ADDITIONAL LIGAMENTOUS INJURY. NO RETROPULSION IS EVIDENT. THE CORD HAS NORMAL SIGNAL. NO DEFINITE CANAL STENOSIS IS NOTED AT THIS TIME. ON (B)(6) 2011: PATIENT PRESENTED WITH THE FOLLOWING PRE OP DIAGNOSES: 1. T9 POSTERIOR FACET AND SPINOUS PROCESS FRACTURE; 2. T10 BURST FRACTURE WITH POSTERIOR AND LAMINA AND SPINOUS PROCESS FRACTURE AND ANTERIOR LIGAMENTOUS DAMAGE BETWEEN T9-T10 PER MRI; 3. THORACOLUMBAR BACK PAIN. PATIENT UNDERWENT THE FOLLOWING PROCEDURES: 1. T8-T12 POSTERIOR THORACIC FUSION WITH PEDICLE SCREW INSTRUMENTATION; 2. RIGHT ILIAC CREST BONE GRAFTING WITH BONE MARROW ASPIRATION AND RHBMP-2/ACS 3. OPEN TREATMENT OF T9 AND T10 THORACIC FRACTURES. IT WAS REPORTED POST OP THAT PATIENT DEVELOPED DECREASED O2 SATURATIONS. IT WAS STATED THAT DECREASED LUNG VOLUMES DUE TO SPINE POSITION AND SURGERY. X-RAYS TAKEN POST UP SHOW POSTERIOR FUSION OF THE THORACOLUMBAR SPINE WITH EXCELLENT POSITION. ON (B)(6) 2011: PATIENT PRESENTED WITH SHORTNESS OF BREATH. CT OF THE CHEST WAS PERFORMED. IMPRESSION: 1. PULMONARY EMBOLI ARE PRESENT IN THE RIGHT LUNG; 2. PARTIAL COLLAPSE OF BOTH LOWER LOBES; 3. SMALL BILATERAL PLEURAL EFFUSION;4. HIATAL HERNIA; 5. FATTY LIVER. X-RAYS OF THE CHEST WERE ALSO TAKEN. IMPRESSION: 1. MINIMAL RIGHT LUNG BASE ATELECTASIS; 2. FOCAL INFILTRATE OR CONSOLIDATION IN THE LEFT LOWER LOBE. ON (B)(6) 2011: VENOUS DUPLEX SCAN WAS PERFORMED BECAUSE OF BILATERAL LEG PAIN. IMPRESSION: THERE IS NO EVIDENCE TO SUGGEST ACUTE DVT IN EITHER LOWER EXTREMITY. ARTERIAL DOPPLER OF THE LEGS WAS ALSO PERFORMED ON (B)(6) 2011. ON (B)(6) 2011: PATIENT PRESENTED COMPLAINING OF THORACIC BACK PAIN AND NUMBNESS OR WEAKNESS OF ARM/LEG. X-RAYS SHOWED STABLE ALIGNMENT AND PLACEMENT OF HARDWARE. ON (B)(6) 2011: PATIENT PRESENTED DENYING ANY PAIN, BURNING, NUMBNESS OR WEAKNESS IN EITHER LOWER EXTREMITY. PATIENT REPORTS INABILITY TO FLEX THE LEFT THUMB PASSIVELY, AND UNABLE TO ACTIVELY FLEX THE IP JOINT. X-RAYS SHOW GOOD PLACEMENT OF HARDWARE, INSTRUMENTATION AND OVERALL ALIGNMENT. ON (B)(6) 2011: PATIENT REPORTED WHAT FEELS LIKE A PINCHED NERVE IN HIS FOREARM STARTING AT THE ELBOW AND TROUBLE WITH ROM IN HIS THUMB. PATIENT PRESENTED FOR MRI OF THE LEFT HAND. IMPRESSION: NO EVIDENCE FOR A FLEXOR POLLICIS LONGUS TENDON TEAR OR TENOSYNOVITIS. MRI OF THE LEFT FOREARM WAS ALSO PERFORMED. IMPRESSION: MYOEDEMA OF THE PRONATOR QUADRATUS AND FLEXOR DIGITORUM PROFUNDUS MUSCLE, BUT NO EVIDENCE FOR TENDON TEAR OR MYOTENDINOUS INFLAMMATION OF THE FLEXOR POLLICIS LONGUS WITHIN THE FOREARM. ON (B)(6) 2011: PATIENT UNDERWENT AN EMG. IMPRESSION: 1. ABNORMAL STUDY; 2. ABNORMAL EMG EXAM FOR THE LEFT UPPER EXTREMITY CONSISTENT WITH ANTERIOR INTER-OSSEOUS NEUROPATHY. THIS IS CONSISTENT WITH PATIENT¿S SIGNS OF FPL WEAKNESS; 3. ABNORMAL EMG EXAM OF THE RIGHT SERRATUS ANTERIOR CONSISTENT WITH LONG THORACIC NEUROPATHY; 4. MEDIAN FOCAL NEUROPATHY AT THE WRISTS, MODERATE IN SEVERITY, THE MEDIAN MOTOR LATENCIES PROLONGED L- 4.7MS R -4.4MS AND PROLONGED MEDIAN SENSORY LATENCIES L -4.5MS R -4.0MS; 5. FOCAL ULNAR NEUROPATHY AT THE RIGHT WRIST CONSISTENT WITH A GUYON¿S CANAL FOCAL LESION, MILD IN SEVERITY; 6. NO EVIDENCE OF FOCAL ULNAR NEUROPATHY IN THE LEFT UPPER EXTREMITY. PATIENT WAS EVALUATED BY PHYSICIAN FOR WEAKNESS OF THE LEFT UPPER EXTREMITY, THUMB, RIGHT SCAPULAR WINGING. ON (B)(6) 2011: PATIENT PRESENTED FOLLOWING CLINICAL EXAMINATION AND EVALUATION THAT SHOWED A LONG THORACIC NERVE PALSY ON A NERVE TEST, AS WELL AS AN ANTERIOR INTER-OSSEOUS NERVE PALSY ON THE LEFT FOREARM WITH SOME FINDINGS OF GUYON¿S CANAL AND CARPAL TUNNEL SYNDROME. PATIENT WAS REFERRED TO A NEUROLOGIST FOR A CONSULTATION AND A SECOND OPINION. X-RAYS OF THE THORACOLUMBAR SPINE SHOWED WELL PLACEMENT OF HARDWARE AND FUSION. OVERALL ALIGNMENT IS INTACT, NO COMPLICATIONS OR CHANGES NOTABLE. ON (B)(6) 2011: PATIENT UNDERWENT CT OF THE THORACIC SPINE. IMPRESSION: 1. T8-T12 POSTERIOR RODDING AND PEDICLE SCREWS IN GOOD POSITION; 2. T10 ANTERIOR COMPRESSION FRACTURE WITHOUT EVIDENCE OF RETROPULSION OF FRACTURE FRAGMENTS. ON (B)(6) 2011: PATIENT PRESENTED WITH PAIN, SPREADING PAIN, AND LUMBAR PAIN. PATIENT ALSO REPORTS TIGHTNESS IN BACK AND WEAKNESS. PATIENT STILL REPORTS TROUBLE WITH THE LEFT THUMB. PATIENT REPORTS RIGHT SHOULDER PAIN AND LIMITED MOVEMENT. X-RAYS OF THE THORACOLUMBAR SPINE SHOW STABLE FUSION, AND INSTRUMENTATION WITH NO COMPLICATIONS. ON (B)(6) 2012: PATIENT PRESENTED TO PHYSICAL THERAPY AND REPORTED SHOULDER SORENESS AND EXHIBITED RIGHT SCAPULAR WINGING MODERATE TO SEVERE. ON (B)(6) 2012: PATIENT PRESENTED WITH OCCASIONAL LUMBAR SORENESS AND STIFFNESS. ON (B)(6) 2012: PATIENT PRESENTED WITH SORENESS, CRAMPING, AND BURNING SENSATION. PATIENT REPORTS PHYSICAL THERAPY IS HELPING SOME. PATIENT HAS SOME DEVELOPING AND PROGRESSING WINGING OF THE RIGHT SCAPULA. PATIENT ALREADY HAD THE PARALYSIS PALSY FOR THE LEFT THUMB FLEXOR POLLICIS LONGUS MUSCLE. X-RAYS WERE TAKEN WHICH SHOWED A STABLE THORACOLUMBAR FUSION WITH NO CHANGES IN TERMS OF INSTRUMENTATION AND BONE GRAFTING AND SPINAL ALIGNMENT. ON (B)(6) 2012: PATIENT PRESENTED WITH A LOT OF GENERALIZED BACK PAIN AND STILL HAS WINGING OF THE RIGHT SCAPULA AND WEAKNESS OF THESE PARASCAPULAR MUSCULAR TISSUES. THE PATIENT REPORTED HAVING SIGNIFICANTLY WEAK AND NON-FUNCTIONAL LEFT THUMB FPL. ON (B)(6) 2013: PATIENT UNDERWENT A NERVE CONDUCTION STUDY. IMPRESSION: 1. BILATERAL CARPAL TUNNEL SYNDROME LEFT WORSE THAN RIGHT; 2. EMG OF LEFT ARM REVEALS MILD ACUTE/CHRONIC DENERVATION CONSISTENT WITH A PROXIMAL INJURY TO THE MEDIAN NERVE ABOVE THE PRONATOR TERES; 3. EMG OF RIGHT UPPER EXTREMITY REVEALS MILD ACUTE/CHRONIC DENERVATION OF RIGHT SERRATUS ANTERIOR CONSISTENT WITH AN INJURY TO THE RIGHT LONG THORACIC NERVE; 4. ALL AFFECTED MUSCLES HAD MOTOR UNITS SO NONE OF THE AFFECTED NERVES WERE COMPLETELY SEVERED. ON (B)(6) 2013: PATIENT PRESENTED WITH NECK PAIN ON BOTH SIDES, RIGHT SHOULDER PAIN, LEFT WRIST PAIN, RIGHT UPPER BACK PAIN, MID BACK PAIN ON BOTH SIDES, AND NUMBNESS IN ARMS AND LEGS. EVALUATION FOUND A PARTIAL NERVE INJURY ON THE LONG THORACIC NERVE ON THE RIGHT ANTERIOR CHEST WALL, CAUSING THE RIGHT SHOULDER BLADE SCAPULAR WINGING AND UNFORTUNATELY ALSO FROM THE TRAUMATIC INJURY IN THE ROLLOVER MVA, WHICH IS WHY THE LEFT THUMB IS WEAK AS WELL. ACCORDING TO THE REPORT, ¿THERE IS NOTHING THAT CAN BE DONE AT THIS POINT, NO NEED FOR SURGICAL EXPLORATION.¿ X-RAYS SHOWED A STABLE MID LOWER THORACIC FUSION AND NO CHANGE IN ALIGNMENT. ON (B)(6) 2013: PATIENT PRESENTED WITH A MEDICAL DIAGNOSES OF WINGED SCAPULA RIGHT SHOULDER AND THORACIC WEAKNESS. ASSESSMENT: WEAK RIGHT MID AND LOWER TRAPEZIUS AND WEAK RIGHT RHOMBOIDS. ON (B)(6) 2013: PATIENT PRESENTED WITH NECK PAIN ON BOTH SIDES, RIGHT SHOULDER PAIN, LEFT WRIST PAIN, RIGHT UPPER BACK PAIN, MID BACK PAIN ON BOTH SIDES, AND NUMBNESS IN ARMS AND LEGS. THE PATIENT ALLEGES NERVE DAMAGE AND PAIN/SWELLING AS DIRECT RESULT OF RHBMP-2/ACS USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 245232 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M111054AAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |