UNKNOWN

Report

Report Number: 1030489-2024-00034
Event Type: Malfunction
Date Received: January 10, 2024
Date of Event: January 8, 2023
Report Date: January 10, 2024
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: MAX
PMA / PMN Number: UNKNOWN
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

RISK FACTORS FOR CAGE MIGRATION FOLLOWING LATERAL LUMBAR INTERBODY FUSION COMBINED WITH POSTERIOR INSTRUMENTATION: HIROAKI KIMURA, SHUNSUKE FUJIBAYASHI, BUNGO OTSUKI, TAKAYOSHI SHIMIZU, KOICHI MURATA, MITSURU TAKEMOTO, SEIICHI ODATE, JITSUHIKO SHIKATA, TAKESHI SAKAMOTO, RYOSUKE TSUTSUMI, MASATO OTA, TOSHIYUKI KITAORI, AND SHUICHI MATSUDA: DOI: 10.1097/BRS.0000000000004602 B3: DATE THAT THE ARTICLE WAS ACCEPTED FOR AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. D4: PRODUCT IDENTIFIERS ARE UNKNOWN. H6: 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. G3: 510(K)# IS UNKNOWN. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

Description of Event or Problem · 0

RISK FACTORS FOR CAGE MIGRATION FOLLOWING LATERAL LUMBAR INTERBODY FUSION COMBINED WITH POSTERIOR INSTRUMENTATION: HIROAKI KIMURA, SHUNSUKE FUJIBAYASHI, BUNGO OTSUKI, TAKAYOSHI SHIMIZU, KOICHI MURATA, MITSURU TAKEMOTO, SEIICHI ODATE, JITSUHIKO SHIKATA, TAKESHI SAKAMOTO, RYOSUKE TSUTSUMI, MASATO OTA, TOSHIYUKI KITAORI, AND SHUICHI MATSUDA: DOI: 10.1097/BRS.0000000000004602 THIS STUDY AIMED TO ELUCIDATE THE INCIDENCE AND RISK FACTORS OF LATERAL CAGE MIGRATION (LCM) AFTER LATERAL LUMBAR INTER BODY FUSION (LLIF) COMBINED WITH POSTERIOR INSTRUMENTATION. LLIF HAS RECENTLY BECOME A WIDELY ACCEPTED PROCEDURE FOR THE TREATMENT OF LUMBAR DEGENERATIVE DISEASES. ALTHOUGH LLIF COMPLICATIONS INCLUDE VASCULAR, NERVE, AND ABDOMINAL ORGAN INJURIES, FEW STUDIES HAVE IDENTIFIED SPECIFIC RISK FACTORS FOR LCM AFTER LLIF. WITH AGING, AN INCREASING NUMBER OF PATIENTS UNDERGO LUMBAR INTERBODY FUSION FOR DEGENERATIVE LUMBAR DISEASES, INCLUDING LUMBAR STENOSIS, SPONDYLOLISTHESIS, DEGENERATIVE DISK DISEASE, AND ADULT SPINAL DEFORMITY. LATERAL LUMBAR INTERBODY FUSION (LLIF), TYPIFIED BY EXTREME LATERAL INTERBODY FUSION AND OBLIQUE LATERAL INTERBODY FUSION (OLIF), HAS BECOME A WIDELY ACCEPTED PROCEDURE BECAUSE OF ITS ADVANTAGES OF DIMINISHED BLOOD LOSS AND QUICKER RETURN TO WORK COMPARED WITH CONVENTIONAL POSTERIOR PROCEDURES SUCH AS POSTERIOR LUMBAR INTERBODY FUSION (PLIF) AND TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF). IN ADDITION, LLIF DECOMPRESSES NEURAL ELEMENTS INDIRECTLY BY RESTORING DISK HEIGHT AND ALLOWS THE CORRECTION OF DEFORMITY IN BOTH THE SAGITTAL AND CORONAL PLANES USING LIGAMENTOTAXIS. THE INCLUSION CRITERIA FOR THIS STUDY WERE AS FOLLOWS: (1) LUMBAR SPINAL CANAL STENOSIS, INCLUDING ADJACENT SEGMENT DISEASE, DEGENERATIVE LUMBAR SCOLIOSIS, AND OSTEOPOROTIC VERTEBRAL FRACTURE¿RELATED DISORDERS CAUSING NEURALGIC OR LUMBAR PAIN. (2) SURGICAL SITES WITHIN THE LUMBOSACRAL AREA. (3) POSTERIOR LUMBAR FUSION SURGERY COMBINED WITH LLIF AT LEVELS L1¿5. (4) ATLEAST ONE-YEAR FOLLOW-UP. THE EXCLUSION CRITERIA WERE AS FOLLOWS (1) TUMOR AND INFECTION AND (2) STAND-ALONE LLIF. ULTIMATELY, 983 PATIENTS WITH A TOTAL OF 1752 LEVELS TREATED WITH LLIF (OLIF: 896 PATIENTS, EXTREME LATERAL INTERBODY FUSION: 87 PATIENTS) WERE INCLUDED. THE MEAN AGE WAS 70.5 (RANGE, 16¿93) YEARS. PATIENTS WERE CLASSIFIED INTO TWO GROUPS: LCM AND NON-LCM. MULTIPLE CLINICAL FACTORS WERE REVIEWED FOR EACH PATIENT, INCLUDING AGE, SEX, PRE-OPERATIVE DIAGNOSIS, FUSION LEVEL, AND SURGICAL APPROACH AND TECHNIQUE. LCM WAS DEFINED AS A CHANGE OF MORE THAN 3 MM IN THE MOVEMENT OF THE RADIOPAQUE MARKER IN THE POSITION OF THE CAGE BY COMPARING POSTOPERATIVE RADIOGRAPHS TO THE IMMEDIATE POSTOPERATIVE RADIOGRAPHS ON THE ANTEROPOSTERIOR RADIOGRAPH. SIXTEEN PATIENTS (10 MEN AND SIX WOMEN, MEAN AGE 70.1 ± 11.3 YR) EXPERIENCED LCM, AND THE INCIDENCE OF LCM AFTER LLIF COMBINED WITH POSTERIOR INSTRUMENTATION. AMONG THE 16 PATIENTS WITH LCM, NINE HAD NO SYMPTOMS, SEVEN HAD LOW BACK PAIN AND/OR RADICULOPATHY, AND SEVEN ACHIEVED BONE UNION DURING FOLLOW-UP. IN ONE PATIENT, A ZONE OF LOOSENING AROUND THE CAGE WAS DETECTED ON POSTOPERATIVE RADIOGRAPHS ONE YEAR AFTER SURGERY, BUT FUSION WAS EVENTUALLY ACHIEVED ON CT IMAGES 1.5 YEARS AFTER SURGERY. THREE PATIENTS UNDERWENT REVISION SURGERIES EXTENDING THE FUSION LEVELS FOR SYMPTOMS RESULTING FROM NONUNION, AND ONE HAD A MIGRATED CAGE REPLACED WITH AN ILIAC BONE GRAFT. SEE ATTACHED LITERATURE ARTICLE. REPORTED EVENTS: 1. 3 PATIENTS HAD CAGE MIGRATION AND HAD REVISION SURGERY WITH LOW BACK PAIN. 2. 4 PATIENTS HAD CAGE MIGRATION WITH LOW BACK PAIN. 3. 9 PATIENTS HAD CAGE MIGRATION WITH NO SYMPTOMS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2551257	UNKNOWN	INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,	MAX	MEDTRONIC SOFAMOR DANEK USA, INC	MSB_UNK_CAGE	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown