InSpace™ 0132Recalls & reported problems
Ortho-Space Ltd · InSpace™ system, Large 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
- 6
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 17290013396065), received between May 10, 2022 and Jan 27, 2026 — classified as 4 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 reports).
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.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem5
- Adverse Event Without Identified Device or Use Problem3
- Appropriate Device Problem Term/Code Not Available1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Unspecified Infection4
- Implant Pain1
- Skin Infection1
- Swelling/ Edema1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Material Fragmentation
IT WAS REPORTED THAT THE METAL TIP THAT CONNECTS TO THE BALLOON WAS BROKEN AND WASN'T ABLE TO FILL THE SALINE TO THE BALLOON. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24195936 ↗InjurySep 15, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED SEVERE SWELLING AND LACK OF MOBILITY AFTER THE DEVICE WAS IMPLANTED IN SHOULDER. THERE WAS POSITIVE CULTURE TEST WITH CUTIEBACTERIUM ACNES.
Patient problems: Swelling/ Edema
MAUDE report 17760181 ↗MalfunctionJul 25, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION THAT REQUIRED A WASH OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 15095154 ↗InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION THAT REQUIRED A WASH OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 15055558 ↗InjuryJun 14, 2022Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION THAT REQUIRED A WASH OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 14688862 ↗InjuryMay 10, 2022Appropriate Device Problem Term/Code Not Available; Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED SHOULDER REQUIRING AN ARTHROSCOPIC WASH OUT.
Patient problems: Implant Pain; No Clinical Signs, Symptoms or Conditions; Skin Infection; Unspecified Infection
MAUDE report 14349738 ↗
Other Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed devices
- InSpace™ 0131Ortho-Space Ltd · Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed11 reports
- InSpace™ 0130Ortho-Space Ltd · Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.