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

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

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - constructs: cslp/unknown lot.Part and lot numbers are unknown; udi 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

The current report is a retrospective analysis of patients, prospectively collected in the swespine registry, who underwent instrumentation with expedium posterior for the period identified between january 02 2006 and november 22, 2020.Indications for instrumentation 817 cases (782 females) were with metastatic malignancy.33 patients had additional anterior instrumentation with non-depuy devices and 1 patient with cslp.The non-depuy devices were excluded, leaving 784 cases for analysis mean age of the patients was 66years.34% females.784 with metastatic malignancy.33 patients had additional anterior instrumentation with non-depuy devices and 1 patient with cslp.This impacted product captures these adverse events: registered intra-operative complications: 18 /784 dural tear, 3/784 medullary injury -2/784 root injury.This impacted product captures these adverse events: 9/784 death.This impacted product captures these events: 12/784 misplaced implant.Readmissions 1: 22 /784 drain infection, 3 /784 redecompression, 3 /784 removal implant, 1/784 repair dural injury, 3 /784 stop bleeding.Readmissions 2: 1 /784 drain hematoma, 3 /784 drain infection, 1 /784 redecompression.784 patient with expedium posterior - metastatic malignancy (proms): pain : worse (n-100) and unchange (n=24).This impacted product captures these events: readmission 1: 6 /784 adjustment implant.Readmission 2: 1 /784 adjustment implant.This is for depuy synthes cslp.A copy of the clinical evaluation form is being submitted with this regulatory report.This report is for one (1) unk - constructs: cslp.This is report 1 of 4 for complaint (b)(4).

Event Description

The current report is a retrospective analysis of patients, prospectively collected in the swespine registry, who underwent instrumentation with expedium posterior for the period identified between january 02 2006 and november 22, 2020.Indications for instrumentation 817 cases (782 females) were with metastatic malignancy.33 patients had additional anterior instrumentation with non-depuy devices and 1 patient with cslp.The non-depuy devices were excluded, leaving 784 cases for analysis mean age of the patients was 66 years.34% females.784 with metastatic malignancy.33 patients had additional anterior instrumentation with non-depuy devices and 1 patient with cslp.This impacted product captures these adverse events: registered intra-operative complications: 18 /784 dural tear, 3/784 medullary injury -2/784 root injury.This impacted product captures these adverse events: 9/784 death.This impacted product captures these events: 12/784 misplaced implant.Readmissions 1: 22 /784 drain infection, 3 /784 redecompression, 3 /784 removal implant, 1/784 repair dural injury, 3 /784 stop bleeding.Readmissions 2: 1 /784 drain hematoma, 3 /784 drain infection, 1 /784 redecompression.784 patient with expedium posterior - metastatic malignancy (proms): pain : worse (n-100) and unchange (n=24).This impacted product captures these events: readmission 1: 6 /784 adjustment implant.Readmission 2: 1 /784 adjustment implant.This is for depuy synthes cslp.A copy of the clinical evaluation form is being submitted with this regulatory report.This report is for one (1) unk - constructs: cslp.This is report 1 of 4 for complaint (b)(4).

Manufacturer Narrative

This report is for an unk - constructs: cslp/unknown lot.Part and lot numbers are unknown; udi 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.

• Brand Name: UNK - CONSTRUCTS: CSLP
• Type of Device: ORTHOSIS, PEDICLE SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12705772
• MDR Text Key: 285151592
• Report Number: 8030965-2021-09059
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention