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InSpace™ 0130Recalls & reported problems

Ortho-Space Ltd · InSpace™ system Small The InSpace™ Subacromial Tissue Spacer System is a Shoulder spacer for massive irreparable rotator cuff tears, resorbable, inflatable, non-fixed. The InSpace™ Subacromial Tissue Spacer System implant is designed to act as a spacer, creating a physical barrier between tissues in the subacromial space. It is supplied sterile (EtO) and intended for single use. · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 17290013396041), received between Mar 22, 2023 and Jun 28, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Component Missing” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Component Missing1
  • Material Rupture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • Pain1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 28, 2023Material Rupture; Material Rupture

    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.

    Patient problems: Pain

    MAUDE report 17221932 ↗
  • InjuryMar 22, 2023Component Missing; Component Missing

    IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16590693 ↗

Other Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed devices

All Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.