MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREW/ROD CONSTRUCT ACCESSORIES; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Bone Fracture(s) (1870); Hematoma (1884); Nerve Damage (1979); Non-union Bone Fracture (2369); Osteolysis (2377); Neck Pain (2433); Post Operative Wound Infection (2446)

Event Type  Injury  

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) from a (b)(6) registry between december 2011 and january 2022, with a total of 321 patients (326 procedures; 116 male and 210 female; mean age of 63.2 years) who were operated with depuy synthes spine plif.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: postoperative general complications: 4 patients had cardiovascular complications.1 patient had pulmonary complications.1 patient had kidney/urinary complications.1 patient had liver/gi complications.1 patient had other complications.Intraoperative surgical complications: 2 patients had nerve root damage.23 patients had dural lesion.1 patient had vascular injury.1 patient had fracture vertebral structures.Postoperative surgical complications: 1 patient had epidural hematoma.3 patients had other hematoma.4 patients had radiculopathy.2 patients had csf leak/pseudomeningocele.2 patients had motor dysfunction.1 patient had bowel/bladder dysfunction.1 patient had deep wound infection.2 patients had implant malpositioned.2 patients had implant failure.3 patients had other complications.Postoperative complications: 5 patients had sensory dysfunction.4 patients had motor dysfunction.5 patients had non-union.6 patients had implant failure.6 patients had instability.1 patient had csf leak/pseudomeningocele.3 patients had superficial wound infection.5 patients had deep wound infection.1 patient had epidural hematoma.1 patient had extravertebral hematoma.4 patients had implant malposition.5 patients had recurrence of symptoms.1 patient had graft complication.9 patients had adjacent segment pathology.2 patients had decompensation of spine.2 patients had cardiovascular complications.1 patient had gastrointestinal complications.6 patients had fracture vertebral structures.1 patient had thromboembolism.12 patients had other complications.Reoperations: 2 patients had reoperations for hardware removal.3 patients had reoperations due to non-union.4 patients had reoperations due to instability.3 patients had reoperations due to failure to reach therapeutic goals.4 patients had reoperations due to neurocompression.3 patients had reoperations due to postoperative superficial infection.2 patients had reoperations due to postoperative deep infection.3 patients had reoperations due to implant malposition.7 patients had reoperations due to implant failure.11 patients had reoperations due to adjacent segment pathology.8 patients had reoperations due to other reasons.This report is for unknown depuy synthes matrix, unknown depuy synthes spine pangea, unknown depuy synthes spine urs, and unknown depuy synthes spine uss and uss ii constructs.This is report 4 of 10 for (b)(4).

• Brand Name: UNK - SCREW/ROD CONSTRUCT ACCESSORIES
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• 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: 13315496
• MDR Text Key: 289183623
• Report Number: 8030965-2022-00482
• Device Sequence Number: 1
• Product Code: MNH
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2022
• 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