MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ALTAPORE; FILLER, BONE VOID, CALCIUM COMPOUND

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

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported from an anonymous survey result that the potential patient response risk with the use of altapore for implantation in place of cortico-cancellous or cancellous allograft or autograft bone in low load or compression environments for plastic/reconstructive surgery procedures was rated as moderate for risk of pseudoarthrosis, specified as ¿some extremity sss as i age cases have had buildup of product leading to pseudoarthrosis in the wrist or ankle regions".Moderate for risk of nonunion, specified as "a few cases of nonunion when used by orthopedist at time of flap coverage over grade iiib tobias fractures", moderate for risk of delayed union, specified as ¿same as above on tibia¿, moderate for risk of repeat surgery, specified as ¿"autologous grafting sometimes necessary to salvage" and moderate for insufficient therapy-insufficient bone growth at graft site, specified as "autologous grafting sometimes necessary to salvage".At the time of this report, no further detail was provided regarding if hospitalization was required, treatment for the event or the patient¿s outcome.No additional information is available.

• Brand Name: ALTAPORE
• Type of Device: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - ELSTREE; 370 centennial avenue; elstree, borehamwood; hertfordshire WD6 3 TJ; UK WD6 3TJ
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 10714376
• MDR Text Key: 212384579
• Report Number: 1416980-2020-06544
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ALTAPORE
• Patient Outcome(s): Other