MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREW/ROD CONSTRUCT ACCESSORIES; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Nerve Damage (1979); Non-union Bone Fracture (2369); Osteolysis (2377); Neck Pain (2433); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) for a total of 156 patients (157 procedures) who were operated with depuy synthes vertebral body replacement from (b)(6) 2011 to (b)(6) 2020.There were 78 females and 79 males with a mean age of (b)(6).It was not specified in the euro spine tango registry report which of the mentioned devices have caused the adverse events.It was also not specified in which country the adverse events have occurred.Thus, each country mentioned in the surgery activity will be captured conservatively and complications will be reported as follows: intraoperative general complications: 1 patient had anesthesiologic complication.2 patients had cardiovascular complication.1 patient had other intraoperative complication.Intraoperative surgical complications: 1 patient had a nerve root damage.9 patients had dural lesion.1 patient had vascular injury.2 patients had fracture of vertebral structures.1 patient had other intraoperative surgical complication.Postoperative general complications: 4 patients had cardiovascular complication.9 patients had pulmonary complication.3 patients had cerebral complication.4 patients had kidney/urinary complication.1 patient had liver/gastrointestinal complication.1 patient had thromboembolism.3 patients had other postoperative complication.Postoperative surgical complications: 1 patient had epidural hematoma.2 patients had other hematoma.1 patient had radiculopathy.1 patient had cerebrospinal fluid leak/pseudomeningocele.8 patients had motor dysfunction.7 patients had sensory dysfunction.2 patients had deep wound infection.3 patients had implant malposition.3 patients had implant failure.7 patients had other postoperative surgical complications.Postoperative complications at follow-up: 14 patients had sensory dysfunction.7 patients had motor dysfunction.1 patient had bowel or bladder dysfunction.4 patients had nonunion.4 patients had implant failure.2 patients had instability.4 patients had cerebrospinal fluid leak/pseudomeningocele.4 patients had superficial wound infection.3 patients had deep wound infection.1 patient had recurrence of symptoms.5 patients had adjacent segment pathology.1 patient had decompensation of spine.1 patient had gastrointestinal complication.5 patients had central nervous system complications.5 patients had fracture of vertebral fractures.1 patient had thromboembolism.11 patients had other complications.Reoperations: 4 patients had reoperation due to hardware removal.1 patient had reoperation due to nonunion.2 patients had reoperation due to instability.1 patient had reoperation due to implant failure.2 patients had reoperation due to sagittal imbalance.2 patients had adjacent segment pathology.1 patient had reoperation for other reasons.This is for the unknown synthes synfix evolution system, unknown synthes synmesh cage, unknown synthes vectra system, unknown synthes cage, unknown synthes cage-expandable peek, unknown synthes click¿x system, unknown synthes cervical spine locking plate (cslp), unknown synthes expandable corpectomy device, unknown synthes thoracolumbar spine locking plate (tslp), unknown synthes matrix spine system, unknown synthes synapse system, unknown synthes syncage, unknown synthes synex c expandable cage, unknown synthes synex l expandable cage, unknown synthes telefix system, unknown synthes transforaminal posterior atraumatic lumbar (t-pal) spacer system, unknown synthes universal spinal system (uss), unknown synthes universal spinal system (uss) ii, unknown synthes xrl cage system, unknown synthes zero-p va cage system, unknown synthes morsher plate, unknown synthes dbx putty, unknown synthes chronos putty, unknown synthes vertecem v+ cement.This is report 3 of 8 for (b)(4).

Manufacturer Narrative

Additional narrative: this report is for an unknown screw/rod construct accessories/ 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.

Manufacturer Narrative

This report is for an unknown screw/rod construct accessories/ 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

This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) for a total of 156 patients (157 procedures) who were operated with depuy synthes vertebral body replacement from march 07, 2011 to january 14, 2020.There were 78 females and 79 males with a mean age of 59 years.It was not specified in the euro spine tango registry report which of the mentioned devices have caused the adverse events.It was also not specified in which country the adverse events have occurred.Thus, each country mentioned in the surgery activity will be captured conservatively and complications will be reported as follows: intraoperative general complications 1 patient had anesthesiologic complication.2 patients had cardiovascular complication.1 patient had other intraoperative complication.Intraoperative surgical complications: 1 patient had a nerve root damage.9 patients had dural lesion.1 patient had vascular injury.2 patients had fracture of vertebral structures.1 patient had other intraoperative surgical complication.Postoperative general complications: 4 patients had cardiovascular complication.9 patients had pulmonary complication.3 patients had cerebral complication.4 patients had kidney/urinary complication.1 patient had liver/gastrointestinal complication.1 patient had thromboembolism.3 patients had other postoperative complication.Postoperative surgical complications: 1 patient had epidural hematoma.2 patients had other hematoma.1 patient had radiculopathy.1 patient had cerebrospinal fluid leak/pseudomeningocele.8 patients had motor dysfunction.7 patients had sensory dysfunction.2 patients had deep wound infection.3 patients had implant malposition.3 patients had implant failure.7 patients had other postoperative surgical complications.Postoperative complications at follow-up: 14 patients had sensory dysfunction.7 patients had motor dysfunction.1 patient had bowel or bladder dysfunction.4 patients had nonunion.4 patients had implant failure.2 patients had instability.4 patients had cerebrospinal fluid leak/pseudomeningocele.4 patients had superficial wound infection.3 patients had deep wound infection.1 patient had recurrence of symptoms.5 patients had adjacent segment pathology.1 patient had decompensation of spine.1 patient had gastrointestinal complication.5 patients had central nervous system complications.5 patients had fracture of vertebral fractures.1 patient had thromboembolism.11 patients had other complications.Reoperations: 4 patients had reoperation due to hardware removal.1 patient had reoperation due to nonunion.2 patients had reoperation due to instability.1 patient had reoperation due to implant failure.2 patients had reoperation due to sagittal imbalance.2 patients had adjacent segment pathology.1 patient had reoperation for other reasons.This is for the unknown synthes synfix evolution system, unknown synthes synmesh cage, unknown synthes vectra system, unknown synthes cage, unknown synthes cage-expandable peek, unknown synthes click¿x system, unknown synthes cervical spine locking plate (cslp), unknown synthes expandable corpectomy device, unknown synthes thoracolumbar spine locking plate (tslp), unknown synthes matrix spine system, unknown synthes synapse system, unknown synthes syncage, unknown synthes synex c expandable cage, unknown synthes synex l expandable cage, unknown synthes telefix system, unknown synthes transforaminal posterior atraumatic lumbar (t-pal) spacer system, unknown synthes universal spinal system (uss), unknown synthes universal spinal system (uss) ii, unknown synthes xrl cage system, unknown synthes zero-p va cage system, unknown synthes morsher plate, unknown synthes dbx putty, unknown synthes chronos putty, unknown synthes vertecem v+ cement.This is report 3 of 8 for (b)(4).

• Brand Name: UNK - SCREW/ROD CONSTRUCT ACCESSORIES
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12917700
• MDR Text Key: 286130583
• Report Number: 8030965-2021-09905
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• 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: 11/18/2021
• 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