MAUDE Adverse Event Report: SYNTHES GMBH UNK - CAGE/SPACERS; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

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  

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 431 patients (432 procedures) who were operated with depuy synthes implants against all other alif procedures recorded within the spine tango registry from (b)(6) 2005 to (b)(6) 2019.There were 276 females and 156 males with a mean age of 59 years.Since it was not specified in which country the adverse events have occurred, each country mentioned in the surgery activity namely: (b)(6) will be conservatively captured in separate product complaints: intraoperative surgical complications: (n=1) nerve root damage, (n=3) dural lesion, (n=4) vascular injury, (n=8) other, (n=8) unknown.Intraoperative general complications: (n=1) not documented, (n=8) unknown.Postoperative general complications: (n=1) cardiovascular, (n=1) pulmonary, (n=1) liver/gi, (n=7) not documented, (n=1) other, (n=8) unknown.Postoperative surgical complications: (n=6) other hematoma, (n=1) radiculopathy, (n=2) motor dysfunction, (n=1) sensory dysfunction, (n=2) implant failure, (n=7) not documented, (n=8) unknown, (n=1) implant malposition.Postoperative complications: (n=5) sensory dysfunction, (n=5) motor dysfunction, (n=2) bowel/bladder dysfunction, (n=1) non-union, (n=5) implant failure, (n=3) instability, (n=7) wound infection superficial, (n=1) wound infection deep, (n-=1) epidural hematoma, (n=1) extravertebral hematoma, (n=6) recurrence of symptoms, (n=3) adjacent segment pathology, (n=1) decompensation of spine, (n=3) fracture vertebral structures, (n=1) thromboembolism, (n=11) other, (n=1) implant malposition.Reoperations at any level: (n=5) hardware removal, (n=2) non-union, (n=5) instability, (n=2) failure to reach therapeutic goals, (n=1) postop deep infection, (n=5) implant failure, (n=2) adjacent segment pathology, (n=3) other, (n=16) unknown.Reoperations at same level: (n=3) hardware removal, (n=3) instability, (n=2) failure to reach therapeutic goals, (n=1) postop deep infection, (n=2) implant failure, (n=2) adjacent segment pathology, (n=2) other, (n=4) unknown.This is for the unknown depuy synthes spine syncage, unknown depuy synthes spine syncage evolution, unknown depuy synthes spine synfix lr , unknown depuy synthes spine synfix evolution, unknown depuy synthes spine synex, unknown depuy synthes spine t-pal, unknown depuy synthes spine oracle, unknown depuy synthes spine tslp , unknown depuy synthes spine atb plate, unknown depuy synthes spine cslp, unknown depuy synthes spine uss, unknown depuy synthes spine chronos, unknown depuy synthes spine chronos putty, unknown depuy synthes spine vertecem , unknown depuy synthes spine vertecem v+, unknown depuy synthes spine matrix, unknown depuy synthes spine travios., unknown depuy synthes spine peek rod.A copy of the clinical evaluation form is being submitted with this regulatory report.This report is for one (1) unk - cage/spacers.This is report 14 of 14 for complaint (b)(4).

Manufacturer Narrative

510k: this report is for an unk - cage/spacers/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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: b5, h6: health effect - clinical code 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: 9 australia surgical forms, no complications for 8 forms and one case of liver / gi postoperative general complication before discharge.

• Brand Name: UNK - CAGE/SPACERS
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• 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: 13666131
• MDR Text Key: 289252179
• Report Number: 8030965-2022-01336
• Device Sequence Number: 1
• Product Code: MAX
• 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,Followup
• Report Date: 03/03/2022

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: 06/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention