MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - CEMENT; POLYMETHYLMETHACRYLATE BONE CEMENT

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

Patient Problems Nerve Damage (1979); Perforation of Vessels (2135); Vertebral Fracture (4520); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown biomaterial-cement/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) from a spine tango registry between february 1, 2005 and september 18, 2021, with a total of 1686 patients (1769 procedures; 926 male and 843 female; mean age of 53.4 years) who were operated with depuy synthes spine anterior cervical interbody.It was not specified in the 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 anaesthesiological complications.1 patient had cardiovascular complications.1 patient had pulmonary complications.Postoperative general complications: 5 patients had cardiovascular complications.12 patients had pulmonary complications.4 patients had cerebral complications.4 patients had kidney/urinary complications.3 patients had liver/gi complications.5 patients died.10 patients had other complications.Intraoperative surgical complications: 3 patients had nerve root damage.16 patients had dural lesion.1 patient had vascular injury.2 patients had fracture vertebral structures.7 patients had other complications.Postoperative surgical complications: 2 patients had epidural hematoma.14 patients had other hematoma.4 patients had radiculopathy.32 patients had motor dysfunction.15 patients had sensory dysfunction.4 patients had bowel/bladder dysfunction.3 patients had wound infection superficial.2 patients had implant malposition.8 patients had implant failure.17 patients had other complications.Postoperative complications: n=145 22 patients had sensory dysfunction.25 patients had motor dysfunction.6 patients had bowel/bladder dysfunction.11 patients had non-union.10 patients had implant failure.1 patient had instability.1 patient had csf leak/pseudomeningocele.10 patients had wound infection superficial.2 patients had wound infection deep.7 patients had epidural hematoma.7 patients had extravertebral hematoma.8 patients had implant malposition.10 patients had recurrence of symptoms.2 patients had graft complication.1 patient had internal medicine complications.11 patients had adjacent segment pathology.1 patient had decompensation of spine.1 patient had gastrointestinal complications.2 patients had central nervous system complications.2 patients had fracture vertebral structures.39 patients had other complications.Reoperations at any level: n=75 (more than 1 reason may be present): 5 patients had reoperations due to hardware removal.7 patients had reoperations due to non-union.4 patients had reoperations due to instability.4 patients had reoperations due to neurocompression.1 patient had reoperations due to postop deep infection.3 patients had reoperations due to implant failure.2 patients had reoperations due to sagittal imbalance.2 patients had reoperations due to adjacent segment pathology.2 patients had reoperations due to other reasons.56 patients had reoperations due to unknown reasons.Reoperations at same level: n=19 (more than 1 reason may be present) 2 patients had reoperations due to hardware removal.3 patients had reoperations due to non-union.1 patient had reoperations due to neurocompression.1 patient had reoperations due to other reasons.13 patients had reoperations due to unknown reasons.This complaint is for unknown depuy synthes spine cslp, unknown depuy synthes spine morsher plate, unknown depuy synthes spine vectra, unknown depuy synthes spine synapse, unknown depuy synthes spine cervifix, unknown depuy synthes spine axon, unknown depuy synthes spine uss, unknown depuy synthes spine synex, unknown depuy synthes spine ecd, unknown depuy synthes spine synmesh, unknown depuy synthes spine zero-p, unknown depuy synthes spine zero-p va, unknown depuy synthes spine acis, unknown depuy synthes spine cervios, unknown depuy synthes spine syncage c, unknown depuy synthes spine cervios chronos, unknown depuy synthes spine dbx, and unknown depuy synthes spine vertecem.This report is for unk - biomaterial - cement.This is report 6 of 8 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.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

Additional complications were reported: 5 australia surgical forms.3 forms with no complications.On one form there is a reported case of pulmonary general complication before discharge.In a separate case, there is one report of "other" - postoperative surgical complication (with a status of resolved).

• Brand Name: UNK - BIOMATERIAL - CEMENT
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• 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: 13662803
• MDR Text Key: 290953826
• Report Number: 8030965-2022-01348
• Device Sequence Number: 1
• Product Code: NDN
• 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,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• 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?: No
• Date Manufacturer Received: 06/10/2022
• 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