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

Catalog Number	0131
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
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 the inspace balloon implant shifted posteriorly in the subacromial space 2 weeks post op.The balloon was deflated upon examination prior to removal.The balloon was removed.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: inspace balloon implant shifted posteriorly in the subacromial space 2 weeks post op probable root cause: process - spacer or plug not manufactured to specification - incorrect size spacer within package application - implant used in contraindicated or ill-advised patient population - user not familiar with device - incorrect spacer size selection - spacer contact with other implants - user underinflated or overinflated spacer - patient noncompliant with post-op rehabilitation schedule or exposed to too intensive pt - use of more than one spacer within joint the reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the inspace balloon implant shifted posteriorly in the subacromial space 2 weeks post op.The balloon was deflated upon examination prior to removal.The balloon was removed.

• Brand Name: INSPACE US MEDIUM
• 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: 19968454
• Report Number: 3016573902-2024-00007
• Device Sequence Number: 8785084
• Product Code: QPQ
• UDI-Device Identifier: 17290013396058
• UDI-Public: 17290013396058
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: DEN200039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: 0131
• Device Lot Number: 130922-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown