MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Nerve Damage (1979); Pain (1994); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown viper implants/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j 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

Device report from depuy spine reports an event in (b)(6) as follows: this report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) to compare usage and outcomes recorded for viper implants in 149 patients (150 procedures) against all other surgical cases recorded within the (b)(6) registry between 2004 and april 19, 2021.There were 60 males and 90 females with a mean age of 63.1 years.Final registry report outcome description: general complications- intraoperative: none.General complications- postoperative surgical before discharge: 3 patients had cardiovascular complications.1 patient had pulmonary complications.2 patients had cerebral complications.5 patients had kidney or urinary complications.2 patients had liver or gastrointestinal complications.2 patients had thromboembolism.4 patients had other complications.3 patients had complications that were not documented.Surgical complications- intraoperative adverse events: 2 patients had nerve root damage.14 patients had dural lesion.2 patients had other intraop adverse events.Surgical complications- postoperative surgical before discharge: 1 patient had epidural hematoma.1 patient had other hematoma.1 patient had radiculopathy.1 patient had csf leak or pseudomeningocele.2 patients had motor dysfunction.2 patients had sensory dysfunction.2 patients had wound deep infection.3 patients had implant malposition 1 patient had implant failure.3 patients had other postoperative surgical complications.3 patients had postoperative surgical complications that were not documented.Reoperations: 17 reoperations at any level at 1 year after surgery.5 reoperations at any level at 2 years after surgery.8 reoperations at any level 1 year after surgery.1 reoperation at any level 2 years after surgery.This is for depuy spine viper implants.This report captures epidural hematoma, other hematoma, radiculopathy, csf leak or pseudomeningocele, motor dysfunction, sensory dysfunction, wound deep infection, implant malposition, implant failure, and other postoperative surgical complications.This is report 2 of 3 for (b)(4).

• Brand Name: UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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 ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11890533
• MDR Text Key: 265277300
• Report Number: 1526439-2021-01043
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2021
• 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