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

Model Number 0132

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2022

Event Type  Injury  

Event Description

It was reported that the patient had an infection that required a wash out.

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.

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.The reported failure mode will be monitored for future reoccurrence.Alleged failure: patient had infection probable root cause: design wrong raw material or manufacturing agent selected in-process cleaning not effective at removing manufacturing residuals not enough strict controls placed on raw material source and purity process sterilization fault - including eto residuals contamination during manufacturing process; including endotoxins in-process cleaning not performed to spec application contamination of instruments patient reaction/allergy sensitivity or with active/latent infection use of contrast media use of more than one implant within the shoulder wrong patient selection manufacture date is not known.

Event Description

It was reported that the patient had an infection that required a wash out.

Event Description

It was reported that the patient had an infection that required a wash out.

Manufacturer Narrative

Correction: the incorrect fda registration number was used during the initial report.The correct fda registration number is 3016573902.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 had infection probable root cause: design - wrong raw material or manufacturing agent selected - in-process cleaning not effective at removing manufacturing residuals - not enough strict controls placed on raw material source and purity process - sterilization fault - including eto residuals - contamination during manufacturing process; including endotoxins - in-process cleaning not performed to spec application - contamination of instruments - patient reaction/allergy sensitivity or with active/latent infection - use of contrast media - use of more than one implant within the shoulder - wrong patient selection product was not received in-house at orthospace-stryker endoscopy, and reportability decision was checked for consistency.

• Brand Name: INSPACE US LARGE
• Type of Device: SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATABL
• Manufacturer (Section D): ORTHOSPACE LTD.; 7 halamish st.; caesarea CA 30795 79; IS 3079579
• Manufacturer (Section G): ORTHOSPACE LTD.; 7 halamish st.; caesarea CA 30795 79; IS 3079579
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 14688862
• MDR Text Key: 294011356
• Report Number: 0002936485-2022-00324
• Device Sequence Number: 1
• Product Code: QPQ
• UDI-Device Identifier: 17290013396065
• UDI-Public: 17290013396065
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2023

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 Model Number: 0132
• Device Catalogue Number: 0132
• Device Lot Number: 291121-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/14/2022
• Supplement Dates Manufacturer Received: 05/18/2022; 05/18/2022
• Supplement Dates FDA Received: 08/15/2022; 02/07/2023
• 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