MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PLATE/SCREWS; ORTHOSIS,PEDICLE,SPINAL FIXATION

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

Patient Problems Nerve Damage (1979); Perforation of Vessels (2135); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - constructs: plate/screws/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.(b)(4).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 755 patients (772 procedures) who were operated with depuy synthes anterior cervical plates from july 26, 2005, to september 18, 2021.There were 364 females and 408 males with a mean age of 54.8 years.It was not specified in the (b)(6) registry report which of the devices mentioned 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 surgical complications: 1 patient had nerve root damage.10 patients had dural lesion.4 patients had other complications.Postoperative complications as follows: general complications: 5 patients had cardiovascular complications.8 patients had pulmonary complications.3 patients had cerebral complications.1 patient had kidney/urinary complications.2 patients had liver/gastrointestinal complications.5 patients died.8 patients had other complications.Surgical complications: 2 patients had epidural hematoma.12 patients had other hematoma.3 patients had radiculopathy.23 patients had motor dysfunction.11 patients had sensory dysfunction.2 patients had bowel/bladder dysfunction.2 patients had wound infection superficial.1 patient had implant malposition.3 patients had implant failure.11 patients had other complications.Complications at follow-up: 16 patients had sensory dysfunction.21 patients had motory dysfunction.2 patients had bowel/bladder dysfunction.9 patients had nonunion.9 patients had implant failure.1 patient had cerebrospinal fluid leak/ pseudomeningocele.6 patients had superficial wound infection.1 patient had deep wound infection.6 patients had epidural hematoma.7 patients had extravertebral hematoma.8 patients had implant malposition.6 patients had recurrence of symptoms.2 patients had graft complication.1 patient had internal medical complication.9 patients had adjacent segment pathology.1 patient had decompensation of spine.2 patients had central nervous system complications.2 patients had fracture of vertebral structures.23 patients had other complications.Reoperations: 29 patients had reoperation at any level.5 patients had reoperation at the same level.4 patients had reoperation due to hardware removal.6 patients had reoperation due to non-union.3 patients had reoperation due to instability.1 patient had reoperation due to deep postoperative infection.4 patients had reoperation due to implant failure.2 patients had reoperation due to sagittal imbalance.4 patients had reoperation due to adjacent segment pathology.1 patient had reoperation due to other reasons.This report is for one (1) unk - constructs: plate/screws.This is report 8 of 8 for complaint (b)(4).

• Brand Name: UNK - CONSTRUCTS: PLATE/SCREWS
• Type of Device: ORTHOSIS,PEDICLE,SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13668225
• MDR Text Key: 291486301
• Report Number: 8030965-2022-01368
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• 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?: Yes
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention