MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: EXPEDIUM; ORTHOSIS, PEDICLE SPINAL FIXATION

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Nerve Damage (1979); Spinal Cord Injury (2432); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4) additional narrative: 510k: this report is for an unk - constructs: expedium/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes reports an event in (b)(6) as follows: the current report is a retrospective analysis of patients, prospectively collected in the swespine registry, who underwent instrumentation with expedium posterior for the period identified between january 02, 2006, and november 22, 2020.Indications for instrumentation were with 3007 cases (2997 female): 1051 were isthmic spondylolysis/-lithiasis and 1956 were ddd and related conditions with a mean age of 51 years.2677 cases (2673 females) were with lumbar spinal stenosis (lss) with a mean age of 64 years.148 cases (146 females) were with degenerative cervico-thoracic spine with a mean age of 64 years.1837 patients were with deformities, with a mean age of 22 years.For meaningful analysis, the cohort was divided into two samples: study sample 1 was restricted to age < 25 years with no previous spine surgery; n = 1316 with a mean age of 15.5 years, and study sample 2 includes patients from age 25 years.N = 329 with mean age of 52 years, females were 71% (available data =324).83 patients had earlier spine surgery.817 cases (782 females) were with metastatic malignancy.33 patients had additional anterior instrumentation with non-depuy devices and 1 patient with cslp.The non-depuy devices were excluded, leaving 784 cases for analysis mean age of the patients was 66years.34% females.And, 141 patients were with infection, 19 were excluded in the analysis, leaving 121 cases with expedium posterior solo.3007 cases (2997 female) : 1051 were isthmic spondylolysis/-lithiasis and 1956 were ddd and related conditions; 2677 cases (2673 females) were with lumbar spinal stenosis (lss); 148 degenerative cervico-thoracic spines; 1316 with deformity (group 1); 329 with deformity (group 2); 784 with metastatic malignancy; 121 with infection.Registered intra-operative complications: 74 /1051 dural tear, 7/1051 root injury, 14/2677 dural tear, 7/148 dural tear, 1/148 horner syndrome, 2/148 recurrent injury, 2/148 oesophagus injury, 1/148 root injury, 7/1316 dural tear, 2/1316 medullary injury, 1//1316 root injury, 36/1316 others, 49/ 329 dural tear, 2/ 329 medullary injury, 2/ 329 root injury, 15/ 329 other, 18 /784 dural tear, 3/784 medullary injury, 2/784 root injury, 1/121 dural injury, 5/121 medullary injury, 2/121 other.2/ 1051 death.5 /1316 death.9/784 death.38/1051 misplaced implant.21/2677 misplaced implant.4/148 misplaced implant.12/784 misplaced implant.8/121 misplaced implant.Reinterventions during index stay: 3/1051 drain infection, 1 /1051 redecompression, 7/1051 removal implant, 4/1051 repair dural injury, 36/1051 adjustment implant, 3/1051 stop bleeding, 12/1051 other, 21/2677 adjustment implant, 1/2677 drain hematoma, 7/2677 drain infection, 3/2677 redecompression, 3/2677 removal implant, 14/2677 repair dural injury, 12/2677 stop bleeding, 9/2677 other, 1 /148 drainage hematoma, 1/148 removal implant, 5 /1316 adjustment implant, 1 /1316 drain deep infection, 5 /1316 removal implant, 5/ 329 adjustment implant, 3/ 329 drain infection, 2/ 329 removal implant, 1/ 329 repair dural injury, 1/ 329 other.Registered post-op complications within 1 year: 12 /1051 pulmonary embolism, 42 /1051 ssi, deep, 156/1051 ssi, superficial, 14/1051 thromboembolism, 9/2677 venus thrombosis, 12/2677 pulmonary embolism, 39/2677 ssi deep, 151/2677 ssi superficial, 1 /148 ssi deep, 7/148 ssi superficial, 4/148 venous thrombosis, 20/121 ssi superficial, 2/121venous thrombosis.Readmissions 1: 1 /1051 drain hematoma, 20 /1051 drain infection, 86 /1051 refusion, 94/1051 removal implant, 4 /1051repair dural injury, 4/1051revision of fusion, 34/1051 other, 3/2677 drain hematoma, 16/2677 drain infection, 19/2677 redecompression, 29/2677 refusion, 47/2677 removal implant, 2/2677 repair dural injury, 5/2677 revision of fusion, 18/2677 other, 3/148 drain deep infection, 1/148 refusion, 1/148 removal implant, 9/1316 drain hematoma, 9/1316 drain infection, 10/1316 removal implant, 9/1316 revision of fusion, 1/329 drain hematoma, 5/ 329 drain infection, 4/ 329 removal implant, 2/ 329 revision of fusion, 5/ 329 other, 22 /784 drain infection, 3 /784 redecompression, 3 /784 removal implant, 1/784 repair dural injury, 3 /784 stop bleeding, 1/121 drain infection, 2/121 removal implant, 2/121 other.Readmissions 2: 6/1051 drain infection, 24/1051refusion, 14/1051 removal implant, 2 /1051 repair dural injury, 7 /1051 other, 5/2677 drain infection, 3/2677 redecompression, 4/2677 refusion, 7/2677 removal implant, 1/2677 repair dural injury, 2 /2677 other, 2/148 drain deep infection, 1 /148 redecompression, 1/1316 drain infection, 2 /1316 removal implant, 7 /1316 other, 2/ 329 drain infection, 8/ 329 removal implant, 6/ 329 revision of fusion, 7/ 329 other, 1 /784 drain hematoma, 3 /784 drain infection, 1 /784 redecompression, 1 /121 removal of implant, 2 /121 other.Readmission 3: 5/1051 refusion, 3/1051 removal implant, 3 /1051 other, 4 /2677 drain infection, 2/2677 removal implant, 7/1316 other, 5/ 329 drain infection, 1/ 329 removal implant, 4/ 329 revision of fusion, 5/ 329 other, readmission 4: 1 /1051 refusion, 2 /1051 removal of implant, 1 /1051 other, 1/2677 drain infection, 1/2677 removal of implant, 1/2677 other, 1/1316 removal of anterior implant, 1/ 329 removal implant, 6/ 329 other.Readmission 5: 1 /1051 other, 1/2677 drain infection, 1/ 329 drain infection, 1/ 329 other.1051 patient with expedium posterior - ddd + isthmic spondylolisthesis: global assessment of back pain failure% fu 1 yr.40% fu 2 yrs.40% fu 5 yrs.38%; global assessment of leg pain (ga) failure% fu 1 yr.39% fu 2 yrs.40% fu 5 yrs.37% 2677 patient with expedium posterior - lumbar spinal stenosis global assessment of back pain failure% fu 1 yr.40% fu 2 yrs.42% fu 5 yrs.46%; global assessment of leg pain (ga) failure% fu 1 yr.34% fu 2 yrs.36% fu 5 yrs.36% 148 patients with expedium posterior - degenerative cervico-thoracic spine global assessment of back pain failure% fu 1 yr.72% fu 2 yrs.58% fu 5 yrs.74%; global assessment of leg pain (ga) failure% fu 1 yr.76% fu 2 yrs.77% fu 5 yrs.93%.784 patient with expedium posterior - metastatic malignancy (proms) pain : worse (n-100) and unchanged (n=24).Readmission 1: 30/1051 adjustment implant, 13/2677 adjustment implant, 1/148 adjustment implant, 14 /1316 adjustment implant, 1/ 329 adjustment implant, 6 /784 adjustment implant.Readmission 2: 4/1051 adjustment implant, 2 /2677 adjustment implant, 4 /1316 adjustment implant, 10 / 329 adjustment implant, 1 /784 adjustment implant.Readmission 3: 1/1051 adjustment implant, 1/2677 adjustment implant, 2/1316 adjustment implant, 1/ 329 adjustment implant.Readmission 4: 3 / 329 adjustment implant.Readmission 5 1 / 329 adjustment implant.This is for depuy spine expedium.This report is for one (1) unk - constructs: expedium.This is report 1 of 4 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: b5, h6 device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Updated event description: this report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra): depuy spinal implants subreport 2024 - expedium posterior taken from swedish spine registry (swespine).Between (b)(6) 2006 and (b)(6) 2023, patients who underwent instrumentation with expedium posterior alone was performed in: 7205 cases with degenerative conditions [ddd + isthmic spondylolysis/-listhesis in 3720 cases (3675 were females; mean age was 50 years) and lumbar spinal stenosis in 3457 cases (3430 were females; mean age was 63 years) and missing in 28 cases]; 216 cases (209 were females; mean age was 65 years) with degenerative cervico-thoracic spine; 2280 cases with deformity [study sample 1 (1713 cases; 66% were females; mean age was 15 years) and study sample 2 (367 cases; 71% were females; mean age was 51 years)]; 945 cases (923 were females; mean age was 67 years) with metastatic malignancy; 185 cases (35% were females; mean age was 62 years) with infection.The following complications in those treated with expedium posterior ¿ degenerative lumbar spine were reported as follows: registered intraoperative complications: (n=1) death (n=96) dural injury (n=42) misplaced implant (n=8) root injury (n=6) hematoma registered post-op complications within 1 year: (n=14) pulmonary embolism (n=213) ssi (n=18) thromboembolism reoperation 1 (n=78) adjustment implant (n=5) drain hematoma (n=27) drain infection (n=110) refusion (n=121) removal implant (n=7) repair dural injury (n=63) other reoperation 2 (n=5) adjustment implant (n=8) drain infection (n=29) refusion (n=24) removal implant (n=3) repair dural injury (n=9) other reoperation 3 (n=1) adjustment implant (n=9) refusion (n=4) removal implant (n=2) drain infection (n=1) repair dural injury (n=3) other reoperation 4 (n=3) refusion (n=2) removal implant (n=2) drain infection (n=1) other reoperation 5 (n=1) drain deep infection (n=1) other reoperation 6 (n=1) drain infection the following complications in those treated with expedium posterior ¿ lumbar spinal stenosis were reported as follows: registered intraoperative complications: (n=2) death (n=196) dural injury (n=29) misplaced implant (n=4) root injury (n=3) cauda equina syndrome (n=22) hematoma registered post-op complications within 1 year (n=13) pulmonary embolism (n=211) infection (n=13) venous thrombosis reoperation 1 (n=39) adjustment implant (n=24) drain hematoma (n=19) drain infection (n=24) redecompression (n=72) refusion (n=58) removal implant (n=18) repair dural injury (n=40) other reoperation 2 (n=4) adjustment implant (n=7) drain infection (n=3) drain hematoma (n=4) redecompression (n=11) refusion (n=12) removal implant (n=1) repair dural injury (n=2) recorrection of deformity (n=5) other reoperation 3 (n=1) adjustment implant (n=4) drain infection (n=2) removal implant (n=2) redecompression (n=2) other reoperation 4 (n=1) drain infection (n=1) removal implant (n=1) refusion (n=1) other the following complications in those treated with expedium posterior ¿ degenerative cervico- thoracic spine were reported as follows: registered intraoperative complications: (n=1) death (n=8) dural injury (n=1) hematoma (n=8) medullary injury (n=4) misplaced implant (n=2) oesophagus injury (n=1) root injury (n=4) other registered post-op complications within 1 year: (n=2) pulmonary embolism (n=10) infection (n=4) venous thrombosis (n=7) vocal cord dysfunction (n=8) dysphagia reoperation 1 (n=1) adjustment implant (n=5) drain infection (n=1) drain hematoma (n=1) redecompression (n=1) refusion (n=4) removal implant reoperation 2 (n=2) drain infection (n=1) redecompression reoperation 3 (n=2) adjustment implant the following complications in those treated with expedium posterior ¿ deformity (study sample 1) were reported as follows: registered intraoperative complications: (n=2) death (n=11) dural injury (n=3) medullary injury - partial (n=1) root injury (n=69) other registered post-op complications within 1 year: (n=5) pulmonary embolism (n=72) infection (n=4) venous thrombosis reoperation 1 (n=23) adjustment implant (n=10) drain hematoma (n=20) drain infection (n=4) recorrection deformity (n=39) removal implant (n=9) revision of fusion (n=30) other reoperation 2 (n=9) adjustment implant (n=4) drain infection (n=3) recorrection deformity (n=1) refusion (n=8) removal implant (n=2) other reoperation 3 (n=2) adjustment implant (n=2) removal implant (n=7) other reoperation 4 (n=1) removal of anterior implant the following complications in those treated with expedium posterior ¿ deformity (study sample 2) were reported as follows: registered intraoperative complications: (n=3) death (n=51) dural injury (n=2) medullary injury (n=2) root injury (n=27) other registered post-op complications within 1 year: (n=10) pulmonary embolism (n=22) infection (n=1) venous thrombosis reoperation 1 (n=22) adjustment implant (n=1) drain hematoma (n=12) drain infection (n=25) removal implant (n=12) revision of fusion (n=25) other reoperation 2 (n=11) adjustment implant (n=2) drain infection (n=11) removal implant (n=6) revision of fusion (n=10) other reoperation 3 (n=2) adjustment implant (n=4) drain infection (n=7) removal implant (n=2) revisio of fusion (n=5) other reoperation 4 (n=2) adjustment implant (n=1) drain infection (n=2) removal implant (n=2) other reoperation 5 (n=1) adjustment implant (n=1) drain infection (n=1) removal implant (n=2) other the following complications in those treated with expedium posterior - metastatic malignancy were reported as follows: registered intraoperative complications: (n=7) death (n=1) thrombosis (n=3) embolism (n=12) hematoma (n=7) infection (n=18) dural injury (n=2) root injury (n=4) medullary injury (n=14) misplaced implant reoperation 1 (n=12) adjustment implant (n=18) drain infection (n=3) redecompression (n=6) removal implant (n=1) repair dural injury (n=5) drain hematoma (stop bleeding) (n=7) other reoperation 2 (n=2) drain infection (n=1) redecompression (n=1) recorrection deformity (n=1) removal implant (n=1) other the following complications in those treated with expedium posterior ¿ infection were reported as follows: registered intraoperative complications: (n=2) dural injury (n=1) hematoma (n=4) misplaced implant (n=2) other registered post-op complications within 1 year: (n=28) infection (n=4) venous thrombosis reoperation 1 (n=5) drain infection (n=3) removal implant (n=1) drain hematoma (n=3) adjustment implant (n=5) other reoperation 2 (n=2) drain infection (n=1) removal implant (n=2) other this is for unknown depuy spine expedium.

• Brand Name: UNK - CONSTRUCTS: EXPEDIUM
• Type of Device: ORTHOSIS, PEDICLE SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12704378
• MDR Text Key: 278573019
• Report Number: 1526439-2021-02257
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention