Delta Xtend 1309-60-315Recalls & reported problems
Depuy (Ireland) · Delta Xtend REVERSE SHOULDER SYSTEM CENTRAL METAGLENE SCREW 6mm x 15mm · Class 2 · Implant
All models of DELTA XTEND (194)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295525202), received between Sep 4, 2025 and Apr 29, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Advance” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Advance2
- Material Deformation2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Bone Fracture(s)1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR DISPLACED TYPE 2B SCAPULAR SPINE FRACTURE DEVICE (RELATEDNESS): PROBABLE PROCEDURE (RELATEDNESS): CAUSAL RELATIONSHIP. DATE OF EVENT: (B)(6) 2023. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: (B)(6) 2025. DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: SURGICAL INTERVENTION FOR THE REGISTRY SHOULDER: YES DATE OF SURGICAL INTERVENTION: (B)(6) 2026, OPEN REDUCTION INTERNAL FIXATION (ORIF): YES, COMPONENTS REMOVED (MARK NONE OR ALL THAT APPLY.):(* PLEASE COMPLETE A PATIENT COMPLETION/DISCONTINUATION FORM.) NONE: YES . DEPUY SYNTHES PRODUCTS USED: TYPE: SCREW. CATALOG NUMBER: 1309603.15. LOT NUMBER: RL295828 DESCRIPTION: CENTRAL METAGLENE SCREW 6MM X 15MM. TYPE: SCREW. CATALOG NUMBER: 130790024. LOT NUMBER: 5547930. DESCRIPTION: DELTA XTEND LOCKING SCREW 4.5 X 24. TYPE: SCREW. CATALOG NUMBER: 130770018. LOT NUMBER: 5819790. DESCRIPTION: DELTA XTEND NON-LOCKING SCREW 4.5 X 18. TYPE: SCREW. CATALOG NUMBER: 130790024. LOT NUMBER: 5552950. DESCRIPTION: DELTA XTEND LOCKING SCREW 4.5 X 24. TYPE: SCREW. CATALOG NUMBER: 130770018. LOT NUMBER: 5829670. DESCRIPTION: DELTA XTEND NON-LOCKING S
Patient problems: Bone Fracture(s)
MAUDE report 25033879 ↗MalfunctionSep 4, 2025Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation
IT WAS REPORTED THAT THERE WERE MAJOR ISSUES WITH THE COLLET NOT ALLOWING GLENOSPHERE SCREW TO THREAD. THE COLLET EXTRACTION TOOL ALSO WOULDN'T FIT INTO THE HOLE. HAD TO USE A DENTAL PICK TO RIP IT OUT. SURGEON WAS FRUSTRATED AND ENDED UP WASTING THE COLLETT, STD CSM BASEPLATE, AND 15 CENTRAL SCREW AND PUTTING IN LEGACY BASEPLATE +10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22961550 ↗MalfunctionSep 4, 2025Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation
IT WAS REPORTED THAT THERE WERE MAJOR ISSUES WITH THE COLLET NOT ALLOWING GLENOSPHERE SCREW TO THREAD. THE COLLET EXTRACTION TOOL ALSO WOULDN'T FIT INTO THE HOLE. HAD TO USE A DENTAL PICK TO RIP IT OUT. SURGEON WAS FRUSTRATED AND ENDED UP WASTING THE COLLETT, STD CSM BASEPLATE, AND 15 CENTRAL SCREW AND PUTTING IN LEGACY BASEPLATE +10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22961547 ↗
Other PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED devices
- DJO SURGICAL 508-32-204Encore Medical, L.P. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall544 reports
- Comprehensive Reverse Shoulder 010000589Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED1 recall142 reports
- DELTA XTEND 130738203Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED175 reports
- DJO SURGICAL 509-00-432Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall117 reports
- Alliance® SBGL3007Zimmer, Inc. · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED162 reports
- DELTA XTEND 130760138Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED146 reports
- DELTA XTEND 130790030Depuy (Ireland) · PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED132 reports
- DJO SURGICAL 509-00-436Encore Medical, L.P. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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