MAUDE Adverse Event Report: ORTHOSPACE LTD. UNKNOWN_ORTHOSPACE_PRODUCT; SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATAB

Catalog Number UNK_ENO

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Swelling/ Edema (4577)

Event Date 10/01/2022

Event Type  Injury  

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.The catalog number is not known at this time, therefore the gtin could not be determined.However, should it become available it will be provided in future reports.

Event Description

It was reported within a publication by (b)(6) that the patient had a balloon migration and an mri scan confirmed anterior migration of the balloon.They also had local warmth and swelling in the anterior aspect of the shoulder.Given the persistence of symptoms, an open surgery by an anterosuperior approach was conducted removing the balloon.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: poor results after arthroscopic treatment of irreparable rotator cuff tears using a subacromial balloon spacer probable root cause: application incorrect spacer size selection patient noncompliant with post-op rehabilitation schedule or exposed to too intensive pt user underinflated or overinflated spacer manufacture date is not known.

Event Description

It was reported within a publication by daniel garriguez-perez that the patient had a balloon migration and an mri scan confirmed anterior migration of the balloon.They also had local warmth and swelling in the anterior aspect of the shoulder.Given the persistence of symptoms, an open surgery by an anterosuperior approach was conducted removing the balloon.

• Brand Name: UNKNOWN_ORTHOSPACE_PRODUCT
• Type of Device: SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATAB
• Manufacturer (Section D): ORTHOSPACE LTD.; 7 halamish st.; caesarea 30795 79; IS 3079579
• Manufacturer (Section G): ORTHOSPACE LTD.; 7 halamish st.; caesarea 30795 79; IS 3079579
• Manufacturer Contact: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 17446828
• MDR Text Key: 320286222
• Report Number: 3016573902-2023-00004
• Device Sequence Number: 1
• Product Code: QPQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN200039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_ENO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2023
• 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
• Patient Outcome(s): Other