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

Catalog Number UNK_ENO

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 07/27/2021

Event Type  Injury  

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.**correction: the correct fda registration number is (b)(4).

Event Description

It was reported that an additional procedure was needed to remove the device due to insufficient clinical improvement and patient pain.

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: continues shoulder pain probable root cause: design - inadequate raw material specification process - spacer not manufactured to specification - incorrect material used during manufacture - incorrect packaging or error in packaging process causes exposure to humidity or high temperatures application - use of expired product - wrong storage conditions (high temperatures or exposure to humidity <40%) - re-use of single-use device - use of contrast media - wrong patient or device selection - patient not following rehab procedure manufacture date is not known.

Event Description

It was reported that an additional procedure was needed to remove the device due to insufficient clinical improvement and patient pain.

• Brand Name: UNKNOWN_ORTHOSPACE_PRODUCT
• Type of Device: SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL
• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16590558
• MDR Text Key: 311775002
• Report Number: 3016573902-2022-00001
• 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: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• 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
• Date Manufacturer Received: 06/24/2022
• 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