INSPACE US MEDIUM
Report
- Report Number
- 3016573902-2024-00005
- Event Type
- Injury
- Date Received
- June 7, 2024
- Date of Event
- May 13, 2024
- Report Date
- July 25, 2025
- Manufacturer
- ORTHOSPACE LTD.
- Product Code
- QPQ
- UDI-DI
- 17290013396058
- PMA / PMN Number
- DEN200039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
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. ALLEGED FAILURE: PATIENT COMPLICATION PROBABLE ROOT CAUSE: 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, RE-USE OF SINGLE-USE DEVICE, USE OF CONTRAST MEDIA, WRONG PATIENT OR DEVICE SELECTION, PATIENT NOT FOLLOWING REHAB PROCEDURE. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. THE MANUFACTURING DATE IS UNKNOWN.
CORRECTING PROBABLE ROOT CAUSES LISTED BELOW AS PER QUALITY ENGINEER REVIEW THESE ARE THE MOST APPLICABLE: 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. ALLEGED FAILURE: PATIENT COMPLICATION PROBABLE ROOT CAUSE: APPLICATION USE OF EXPIRED PRODUCT WRONG STORAGE CONDITIONS RE-USE OF SINGLE-USE DEVICE USE OF CONTRAST MEDIA WRONG PATIENT OR DEVICE SELECTION PATIENT NOT FOLLOWING REHAB PROCEDURE. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. THE MANUFACTURING DATE IS UNKNOWN.
PER ADDITIONAL REVIEW, THE BELOW IS THE UPDATED INVESTIGATION CONCLUSION. 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. ALLEGED FAILURE: PATIENT COMPLICATION PROBABLE ROOT CAUSE: APPLICATION - PATIENT REACTION/ALLERGY SENSITIVITY WITH OR - SURGICAL PROCEDURE INTRODUCES ACTIVE/LATENT INFECTION - WRONG PATIENT SELECTION - GENERAL REACTION TO PROCEDURE THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. STRYKER WILL CONTINUE TO MONITOR FOR ANY REPORTS OR TRENDS.
IT WAS REPORTED THAT THE PATIENT HAD A SUBCUTANEOUS DEVELOPMENT OF ¿COTTAGE CHEESE¿ TYPE CONSISTENCY.
IT WAS REPORTED THAT THE PATIENT HAD A SUBCUTANEOUS DEVELOPMENT OF ¿COTTAGE CHEESE¿ TYPE CONSISTENCY.
IT WAS REPORTED THAT THE PATIENT HAD A SUBCUTANEOUS DEVELOPMENT OF ¿COTTAGE CHEESE¿ TYPE CONSISTENCY.
IT WAS REPORTED THAT THE PATIENT HAD A SUBCUTANEOUS DEVELOPMENT OF ¿COTTAGE CHEESE¿ TYPE CONSISTENCY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1436969 | INSPACE US MEDIUM | SHOULDER SPACER FOR MASSIVE IRREPARABLE ROTATOR CUFF TEAR, RESORBABLE, INFLATAB | QPQ | ORTHOSPACE LTD. | 091123-01 | 17290013396058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |