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

Catalog Number	0130
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3016573902-2023-00002
• Device Sequence Number: 15196026
• Product Code: QPQ
• UDI-Device Identifier: 17290013396041
• UDI-Public: 17290013396041
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: DEN200039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Female