MAUDE Adverse Event Report: DJO LLC MAXTRAX 2.0, AIR, TALL, M; ORTHOSIS, CORRECTIVE SHOE

Model Number 79-95725

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 08/12/2022

Event Type  Injury  

Event Description

It was reported that allegedly 3 patients developed skin breakdown needing wound care with one needing a skin graft and one borderline anterior tibial tendon exposure, though not infected.

Manufacturer Narrative

It was reported that allegedly 3 patients developed skin breakdown needing wound care with one needing a skin graft and one borderline anterior tibial tendon exposure, though not infected.The devices are scheduled to be returned for evaluation, enovis will provide a supplemental when investigations are completed.

• Brand Name: MAXTRAX 2.0, AIR, TALL, M
• Type of Device: ORTHOSIS, CORRECTIVE SHOE
• Manufacturer (Section D): DJO LLC; 5919 sea otter place; ste 200; carlsbad CA 92010
• Manufacturer (Section G): DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.; carretera libre tijuana tecate; 20230 parque industrial el flo; tijuana, b.c. 22245 ; MX 22245
• Manufacturer Contact: jim pomeroy ; 5919 sea otter place; ste 200; carlsbad, CA 92010
• MDR Report Key: 15396763
• MDR Text Key: 299662027
• Report Number: 9616086-2022-00026
• Device Sequence Number: 1
• Product Code: KNP
• UDI-Device Identifier: 00190446665939
• UDI-Public: 00190446665939
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 79-95725
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other