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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Cerebrospinal Fluid Leakage (1772); Bone Fracture(s) (1870); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Non-union Bone Fracture (2369); Osteolysis (2377); Impaired Healing (2378); Neck Pain (2433); Post Operative Wound Infection (2446); Thromboembolism (2654); Joint Laxity (4526); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown mono/polyaxial screw/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing discectomy and fusion.Failed discectomy and fusion has been identified as the reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: intraop general complications: 1 patient had anaesthesiological complications, 1 patient had other complications, 1 patient had complications that were not documented.Surgical complications: intraop adverse events, 18 patients had dural lesions, 3 patients had other complications.Postop general before discharge: 2 patients had cardiovascular complications, 4 patients had pulmonary complications, 3 patients had kidney/urinary complications, 2 patients had liver/gi complications, 1 patient had 1 hromboembolism complications , 2 patients had other complications.Surgical complications: postop surgical before discharge, 1 patient had epidural hematoma, 4 patients had other hematoma, 3 patients had radiculopathy, 3 patients had csf leak / pseudomeningocele, 5 patients had motor dysfunction, 2 patients had sensory dysfunction, 2 patients had bowel / bladder dysfunction, 2 patients had wound infection deep, 2 patients had other complications, 1 patient had implant failure.Reoperations: 35 patients had reoperations at 1 year, 4 patients had reoperations at 2 years, 1 patient had a reoperation at 3 years, 1 patient had a reoperation at 4 years.Surgical complications: postop surgical before discharge, 5 patients had implant malposition.This report is for an expedium.This report is for one (1) unknown mono/polyaxial screw.This is report 3 of 3 for (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: b2 b5 d3 h6 coding.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 database related research activity (drra): spine tango implant report ¿ expedium, in a total of 2431 patients (2522 procedures; 1083 male and1439 female; mean age was 64.7 years) from december 21, 2011 to january 16, 2024.The following complications have been identified per country: belgium (n=14).Postoperative general complications - before discharge: (n=1) liver / gi.(n=1) other.(n=1) positioning-related.(n=1) pulmonary.Intraoperative surgical complications: (n=1) dural lesion.Postoperative surgical complications - before discharge: (n=1) wound infection deep.Reoperations at any level due to: (n=3) postoperative infection deep.(n=1) sagittal imbalance.(n=4) hardware removal.Reoperations at adjacent level due to: (n=1) postoperative infection deep.(n=1) sagittal imbalance.(n=3) hardware removal.Reoperations at same level due to: (n=1) postoperative infection deep.(n=1) sagittal imbalance.(n=3) hardware removal.Portugal (n=1) postoperative surgica.L complications - before discharge: (n=1) radiculopathy.Slovenia (n=7).Intraoperative surgical complications: (n=4) dural lesion.(n=1) fracture vertebral structures.Postoperative surgical complications - before discharge: (n=1) csf leak / pseudomeningocele.(n=1) implant malposition.Switzerland (n=443).Intraoperative general complications: (n=5) anaesthesiological.(n=4) cardiovascular.(n=1) other.(n=1) pulmonary.(n=3) thromboembolism.Postoperative general complications - before discharge: (n=6) cardiovascular.(n=4) other.(n=6) pulmonary.(n=1) thromboembolism.(n=2) cerebral.(n=1) death.(n=4) kidney / urinary.(n=3) liver / gi.(n=1) positioning-related.Intraoperative surgical complications: (n=143) dural lesion.(n=10) fracture vertebral structures.(n=2) nerve root damage.(n=23) other.(n=1) spinal cord damage.Postoperative surgical complications - before discharge: (n=4) other (n=3) bowel / bladder dysfunction (n=5) csf leak / pseudomeningocele (n=3) epidural hematoma (n=3) implant failure (n=5) implant malposition (n=8) motor dysfunction (n=4) other hematoma (n=4) radiculopathy (n=4) sensory dysfunction (n=4) wound infection deep (n=2) wound infection superficial surgery follow-up complications - early (< 28 days): (n=3) csf leak/ pseudomeningocele (n=1) discitis (n=1) implant malposition (n=5) motor dysfunction (n=2) other (n=1) recurrence of symptoms (n=3) sensory dysfunction (n=1) wound infection superficial surgery follow-up complications - sub-acute (2-6 months): (n=1) csf leak/ pseudomeningocele (n=2) extravertebral hematoma (n=1) fracture vertebral structures (n=1) other (n=1) wound infection deep surgery follow-up complications - late (> 6 months) (n=1) csf leak/ pseudomeningocele (n=1) implant malposition (n=1) instability (n=1) other reoperations at any level due to: (n=19) implant failure (n=9) adjacent segment pathology (n=10) neurocompression (n=9) instability (n=8) failure to reach therapeutic goals (n=12) wound healing problem (n=7) postoperative infection superficial (n=7) postoperative infection deep (n=9) non-union (n=2) spinal imbalance (n=11) hardware removal (n=2) implant malposition (n=2) csf-leak (n=16) other (n=23) unknown reoperations at adjacent level due to: (n=14) implant failure (n=8) adjacent segment pathology (n=8) neurocompression (n=9) instability (n=7) failure to reach therapeutic goals (n=9) wound healing problem (n=4) postoperative infection superficial (n=6) postoperative infection deep (n=7) non-union (n=2) spinal imbalance (n=9) hardware removal (n=1) implant malposition (n=1) csf-leak (n=12) other (n=7) unknown reoperations at same level due to: (n=17) implant failure (n=4) adjacent segment pathology (n=8) neurocompression (n=8) instability (n=7) failure to reach therapeutic goals (n=10) wound healing problem (n=6) postoperative infection superficial (n=6) postoperative infection deep (n=9) non-union (n=2) spinal imbalance (n=9) hardware removal (n=1) implant malposition (n=1) csf-leak (n=11) other (n=7) unknown united kingdom (n=6) postoperative general complications - before discharge: (n=1) kidney / urinary (n=1) pulmonary (n=1) thromboembolism intraoperative surgical complications: (n=1) dural lesion postoperative surgical complications- before discharge: (n=1) bowel / bladder dysfunction (n=1) implant failure this is for an unknown depuy spine expedium.

• Brand Name: UNK - CONSTRUCTS: EXPEDIUM
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS 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 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 12303558
• MDR Text Key: 266044651
• Report Number: 1526439-2021-01658
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 11/19/2021; 03/21/2024
• Supplement Dates FDA Received: 12/16/2021; 04/05/2024
• 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