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

Catalog Number 0130

Device Problem Material Rupture (1546)

Patient Problem Pain (1994)

Event Date 06/01/2023

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.

Event Description

It was reported that several weeks post inspace implant the patient had significant pain.Upon imaging it was determined that the inspace balloon had deflated.Ultimately patient was counseled by the surgeon to proceed with reverse total shoulder, during which the inspace was removed.

Event Description

It was reported that several weeks post inspace implant the patient had significant pain.Upon imaging it was determined that the inspace balloon had deflated.Ultimately patient was counseled by the surgeon to proceed with reverse total shoulder, during which the inspace was removed.

Manufacturer Narrative

Device investigation conclusions: based on the event description by the user and visual inspection of the returned device, it can be concluded that: 1) the device dhr is complete.The device lot was released for commercial and clinical use according to specifications.2) the balloon was received deflated with an observed tear.The visual inspection corresponds to the complaint.3) there is no possibility to determine when and how the tear did occur.Therefore: the root cause cannot be determined.In the event that further information is received, the complaint will be reopened and the investigation will be updated with new results.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: INSPACE US SMALL
• 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: 17221932
• MDR Text Key: 318073072
• Report Number: 3016573902-2023-00002
• Device Sequence Number: 1
• Product Code: QPQ
• UDI-Device Identifier: 17290013396041
• UDI-Public: 17290013396041
• 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: Health Professional
• Reporter Occupation: Physician
• 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: 06/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0130
• Device Lot Number: 310522-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 82 YR
• Patient Sex: Female