MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE ATTRAX PUTTY; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number	5015001
Medical Device Problem Codes	Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device returned as it was left in-situ.No lab reports were received, therefore the complaint cannot be confirmed.The root cause has not yet been determined, the manufacturer is currently investigating the reported claim.A follow-up will be completed if more information is obtained.Labeling review: ".Contraindications: use of attrax putty is contraindicated in the presence of one or more of the following clinical situations: in cases of acute and chronic infections in the operated area (soft tissue infections; inflamed, bacterial bone diseases; osteomyelitis)." ".Warnings, cautions and precautions: inspect all packaging and components for damage before use.Do not use the device if it is damaged in any way.Dosage is for single use only.Do not re-sterilize.Confirm expiration date before use.Do not use if expiration date has been exceeded." ".Pre-operative warnings:1.Only patients that meet the criteria described in the indications should be selected.2.Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.3.Care should be used in the handling and storage of the device.4.Devices should be inspected for damage prior to implantation.5.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".Packaging: packages for each of the components should be intact upon receipt.Damaged packages or products should not be used, and should be returned to nuvasive." ".Sterilization: attrax putty is provided sterile (e-beam irradiation).Do not resterilize." ".How supplied: attrax putty is provided as a sterile, single-use device.Do not use if package is opened or damaged.".
Event or Problem Description
On (b)(6) 2021 nuvasive received a letter from (b)(6) hospital requesting information about possible postoperative infections involving attrax putty.The specific organism of concern is mycobacterium fortuitum.
Event or Problem Description
New information listed in h10.
Additional Manufacturer Narrative
No device returned as it was left in-situ.No lab reports were received, therefore the complaint cannot be confirmed.A sample from the same lot/donor was sent to a third party lab for evaluation where no organisms were identified and no nuvasive products are suspected as being the root cause of the reported infection though environmental contamination maybe related.No additional investigation required.Labeling review: ".Contraindications: use of attrax putty is contraindicated in the presence of one or more of the following clinical situations: in cases of acute and chronic infections in the operated area (soft tissue infections; inflamed, bacterial bone diseases; osteomyelitis).".".Warnings, cautions and precautions: inspect all packaging and components for damage before use.Do not use the device if it is damaged in any way.Dosage is for single use only.Do not re-sterilize.Confirm expiration date before use.Do not use if expiration date has been exceeded.".".Pre-operative warnings:1.Only patients that meet the criteria described in the indications should be selected.2.Patient condition and/or predispositions such as those addressed in the aforementioned.Contraindications should be avoided.3.Care should be used in the handling and storage of the device.4.Devices should be inspected for damage prior to implantation.5.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient.".".Packaging: packages for each of the components should be intact upon receipt.Damaged packages or products should not be used, and should be returned to nuvasive.".".Sterilization: attrax putty is provided sterile (e-beam irradiation).Do not resterilize.".".How supplied: attrax putty is provided as a sterile, single-use device.Do not use if package is opened or damaged.".

• Brand Name: NUVASIVE ATTRAX PUTTY
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 11335498
• Report Number: 2031966-2021-00031
• Device Sequence Number: 16358482
• Product Code: MQV
• UDI-Device Identifier: 00887517241528
• UDI-Public: 887517241528
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191974
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: 5015001
• Device Lot Number: AX16649
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 02/16/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5015002.
• Outcome Attributed to Adverse Event: Other; Required Intervention