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

Catalog Number UNK_ENO

Device Problems Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923)

Patient Problems Erythema (1840); Synovitis (2094); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2020

Event Type  Injury  

Event Description

It was reported within a publication by aristotelis kaisidis that "one patient required a revision procedure for spacer migration at three days.This patient was treated by revision surgery with a new sized subacromial spacer.".

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.The catalog number is not known at this time, therefore the gtin could not be determined.However, should it become available it will be provided in future reports.

Manufacturer Narrative

This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: patient synovitis.Probable root cause: design: inadequate spacer design.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.Manufacture date is not known.H3 other text : 81.

Event Description

It was reported within a publication by aristotelis kaisidis that "one patient required a revision procedure for spacer migration at three days.This patient was treated by revision surgery with a new sized subacromial spacer.".

• Brand Name: UNKNOWN_ORTHOSPACE_PRODUCT
• 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: 17446111
• MDR Text Key: 320287060
• Report Number: 3016573902-2023-00008
• Device Sequence Number: 1
• Product Code: QPQ
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_ENO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 06/02/2023
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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