INFUSE BONE GRAFT
Report
- Report Number
- 1030489-2013-00519
- Event Type
- Injury
- Date Received
- February 15, 2013
- Report Date
- October 26, 2017
- 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).
(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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ON (B)(6) 2006 ¿ PT. UNDERWENT PROCEDURE FOR LEFT L4 HEMILAMINECTOMY, L2-L5 POSTEROLATERAL FUSION WITH PEDICLE SCREW FIXATION, TLIF L3-4 AND L4-5 WITH PEEK SPACER. CENTRAL PORTION OF THE PEEK SPACERS WERE PACKED WITH RHBMP-2/ACS AND CANCELLOUS AUTOGRAFT. POSTEROLATERAL GUTTERS WERE PACKED WITH AUTOGRAFT, ALLOGRAFT, AND RHBMP-2/ACS. ON (B)(6) 2006 ¿ ¿HE STILL IS IN CONSIDERABLE PAIN.¿ ON (B)(6) 2006 - HE IS AFEBRILE. HIS BACK PAIN IS MARKEDLY IMPROVED, AS WELL AS HIS GROIN PAIN. HE CONTINUES TO STRUGGLE WITH HIS ANTERIOR THIGH PAIN. HE HAS SOME WEAKNESS ON LEFT FLEXION. HE STATES PUTTING PAIN ON HIS LEG DOES NOT APPEAR TO CAUSE WORSENING OF HIS LEFT ANTERIOR THIGH PAIN. HE HAS NO NEUROLOGIC SYMPTOMS OTHERWISE AND HIS FEMORAL NERVE IS NON-TENDER AND THE SCIATIC NOTCH IS NON-TENDER.¿ ON (B)(6) 2006 ¿ LUMBAR CT SHOWS ¿BIPEDICULAR SCREWS L2, L3, L4, AND L5 ARE NOTED AND APPEAR UNCOMPLICATED. THERE IS APPROXIMATELY 1 CM OF RETROLISTHESIS AT L2-3.¿ ON (B)(6) 2006 ¿ PT. PRESENTS TO PHYSICAL THERAPY EVALUATION. ¿HE STATES THAT THE SURGERY HAS HELPED WITH HIS SEVERE SYMPTOMS, HOWEVER HE CONTINUES TO STRUGGLE WITH NUMBNESS AROUND HIS SURGERY SITE, AND WORSENING PAIN IN HIS BACK WITH PROLONGED STANDING OR WALKING.¿ ON (B)(6) 2007 ¿ LUMBAR CT SHOWS ¿THERE ARE MARKED POSTOPERATIVE AND CHRONIC-APPEARING CHANGES. THERE IS RETROLISTHESIS OF L2 ON L3. SPINAL STENOSIS DOES NOT APPEAR TO BE PRODUCED.¿ ON (B)(6) 2007 ¿ PT. ¿STATES HE CONTINUES TO STRUGGLE WITH SOME LOWER LUMBAR PAIN, PARTICULARLY IN THE PARAVERTEBRAL MUSCULATURE. HE HAS SOME MILD RADIATION INTO HIS BUTTOCK AREAS, BUT THE PAIN IS MARKEDLY IMPROVED COMPARED TO PREOPERATIVELY.¿ ON (B)(6) 2007 ¿ ¿HIS BACK PAIN HAS MARKEDLY IMPROVED AS WELL AS HIS LOWER EXTREMITY PAIN.¿ ¿HE DOES NOTE THAT HE HAS INTERMITTENT SPASMS AND PAIN INVOLVING HIS PARAVERTEBRAL MUSCULATURE.¿ ON (B)(6) 2007 ¿ CERVICAL MRI SHOWS ¿MULTIPLE CENTRAL AND BROAD-BASED CERVICAL DISC HERNIATIONS ARE PRESENT. MILD SPINAL STENOSIS AT C3-4, C4-5, C5-'6, C6-7 ANDT1-T2 ARE PRESENT.¿ ON (B)(6) 2007 ¿ PT. BEGAN A SERIES OF THREE CERVICAL EPIDURAL STEROID INJECTIONS. ON (B)(6) 2008 ¿ PT. PRESENTS FOR FOLLOW-UP ¿COMPLAINING OF SIGNIFICANT LOW BACK PAIN.¿ ¿HE¿S NOT HAVING ANY RADICULAR SYMPTOMS.¿ ON (B)(6) 2008 ¿ LUMBAR X-RAYS SHOW ¿SOLID APPEARING FUSION OF THE LOWER LUMBAR SPINE IS NOTED. ADVANCED DEGENERATIVE DISC DISEASE AND FACET ARTHROSIS LUMBAR SPINE IS PRESENT.¿ ON (B)(6) 2008 ¿ PT. PRESENTS TO PHYSICAL THERAPY EVALUATION. PT. ¿STATES THAT HE STRUGGLES WITH CONSTANT BACK PAIN THAT WORSENS WITH WALKING. HE STATES THAT THE PAIN AND NUMBNESS SPREADS TO THE OUTSIDE OF HIS HIPS.¿ ON (B)(6) 2008 - PT. UNDERWENT PROCEDURE FOR LUMBAR EPIDURAL STEROID INJECTION. ON (B)(6) 2008 ¿ PT. UNDERWENT PROCEDURE FOR LUMBAR EPIDURAL STEROID INJECTION. ON (B)(6) 2009 -PT. UNDERWENT PROCEDURE FOR LUMBAR EPIDURAL STEROID INJECTION. ON (B)(6) 2009 - PT. UNDERWENT PROCEDURE FOR LUMBAR EPIDURAL STEROID INJECTION. ON (B)(6) 2009 - PT. UNDERWENT PROCEDURE FOR CERVICAL EPIDURAL STEROID INJECTION. ON (B)(6) 2010 ¿ PT. PRESENTS FOR VISIT WITH CHRONIC LOW BACK PAIN AND DEGENERATION OF CERVICAL DISC. ON (B)(6) 2010 - PT. UNDERWENT PROCEDURE FOR CERVICAL EPIDURAL STEROID INJECTION. ON (B)(6) 2012 ¿ PT. PRESENTS FOR VISIT WITH CHRONIC LOW BACK PAIN AND DEGENERATION OF CERVICAL DISC.
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE USING RHBMP-2/ACS. POST-OP, THE PATIENT DEVELOPED "SIGNIFICANT PAIN AND REQUIRED ME TO SEE A DOCTOR FREQUENTLY AFTER SURGERY AND HAS ME CONSTANTLY WORRIED ABOUT WHETHER THINGS WILL GET WORSE."
IT WAS REPORTED THAT THE PATIENT UNDERWENT FUSION SURGERY IN WHICH RHBMP-2/ACS WAS USED. AS PER THE OPERATIVE NOTES, ¿....SURGEON EXPOSED THE L4-5 DISK AND THEN DECOMPRESSED WITH PITUITARY RONGEUR. SURGEON THEN USED A SERIES OF CURETTES TO PREPARE THE INTERSPACE FOR PLACEMENT OF A PEEK SPACER. SURGEON THEN PLACED A PEEK SPACER IN THE INTERSPACE WITHOUT DIFFICULTY, PRIOR TO PLACING THIS SURGEON PACKED THE CENTRAL PORTION OF THIS PEEK SPACER FROM THEKEN WITH RHBMP-2/ACS AND CANCELLOUS AUTOGRAFT. SURGEON PLACED SOME AUTOGRAFT BEHIND THE PEEK SPACER ALSO. SURGEON THEN PLACED FIBER AND GLUE OVER THE LAMINAR DEFECT TO PROTECT THE DURA FROM EFFECTIVE RHBMP-2/ACS. SURGEON THEN PERFORMED A SIMILAR PROCEDURE AT L3. HOWEVER, THERE WAS A PREVIOUS SURGERY; AND SURGEON HAD TO SHARPLY DISSECT THROUGH ABNORMAL TISSUE TO IDENTIFY THE THECAL SAC. SURGEON ALSO HELPED BY EXPOSING NORMAL THECA BY REMOVING THE LAMINA OF L3. SURGEON THEN INCISED THE DISK AND WHILE DOING THIS, SURGEON MADE A SMALL TEAR IN THE DURA AT THIS LEVEL. THERE WAS NOT ANY CSF LEAK. SURGEON THEN INCISED THE DISK AND DECOMPRESSED IT. THIS DISK WAS MARKEDLY DEGENERATED. SURGEON THEN PREPARED THE ENDPLATE WITH A SERIES OF CURETTE FROM THIS DEVICE, THE SET. SURGEON THEN PLACED AN 8MM IN HEIGHT THEKEN PEEK SPA CER. AGAIN, SURGEON PACKED THIS WITH CANCELLOUS BONE AND RHBMP-2/ACS.¿ THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRA-OPERATIVE COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 68512 | INFUSE BONE GRAFT | FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET | NEK | MEDTRONIC SOFAMOR DANEK USA, INC | NA | M115006AAF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |