AXSOS 627204Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327091090), received between Oct 28, 2019 and Oct 28, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2019Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING EVENT WAS REPORTED: SURGERY IS INDICATED BY THE TEARING OF CERCLAGE OSTEOSYNTHESIS SUTURES ON TWO OCCASIONS WITH A HORIZONTAL STABLE-ANGLE PROXIMAL HUMERUS PLATE [FROM STRYKER]. IN DEPTH PREPARATION WITH DELTA-SPLIT ENTRY. LOCATION OF THE PLATE AND SWABBING OF THE HUMERUS PLATE. IF THE KNOTS ARE STILL INTACT, FURTHER PREPARATION WILL INVOLVE CUTTING THROUGH THE STITCH CERCLAGE. MOBILIZATION OF THE FRAGMENT OF THE TUBERCULUM MAJUS AND ENCIRCLEMENT WITH A TOTAL OF FOUR FIBER WIRE RETRACTION SUTURES. THE STITCHES ARE PASSED THROUGH THE HOLES IN THE PLATES AND KNOTTED. TWO SUTURES ARE ALREADY TEARING. REMOVAL OF THE PLATE AND A RENEWED ATTEMPT IN VITRO WITH ONE SUTURE. HERE AGAIN THE SUTURE TEARS. THE PLATE IS OBVIOUSLY UNSUITABLE AND IS THEREFORE REPLACED WITH A PROXIMAL HUMERUS PLATE FROM SYNTHES. THE TOTAL OF FOUR CERCLAGES AND KNOTS ARE NOW PASSED THROUGH THE SUTURE HOLES. THE FINAL X-RAY CHECK SHOWS A CORRECTLY POSITIONED TUBERCULUM FRAGMENT AND ALSO A CORRECTLY POSITIONED SYNTHES PLATE. THIS PI IS FOR THE 3RD MEDICAL INTERVENTION DURING WHICH THE PLATE WAS REMOVED.

  Patient problems: Failure of Implant

  MAUDE report 9244241 ↗
• InjuryOct 28, 2019Device Dislodged or Dislocated

  THE FOLLOWING EVENT WAS REPORTED: SURGERY IS INDICATED BY THE SECOND DISLOCATION OF THE LEFT TUBERCULUM MAJUS FRAGMENT IN A CRANIAL DIRECTION. SCAR TISSUE EXCISION. IN-DEPTH PREPARATION AND LOCATION OF THE STRYKER PLATE USED AS AN ANCHOR POINT FOR CERCLAGE. SWAB PREPARATION. REMOVAL OF THREE SCREWS FROM THE HEAD, DETACHMENT OF ADHESIONS, THEN THREE ENCIRCLEMENTS WITH SINGLE RETRACTION STITCHES OF THE TUBERCULUM FRAGMENT, WHICH IS KNOWN TO HAVE SPLINTERED SEVERAL TIMES. THESE THREE RETRACTION STITCHES ARE TIED TO THE PLATE AS A CERCLAGE. AS A RESULT, THE TUBERCULUM FRAGMENT IS NOW LARGELY ANATOMICAL ONCE AGAIN, THE INITIAL IMPEDED EXTERNAL ROTATION CAN NOW BE PERFORMED AGAIN TO 20 DEGREES. REINSERTION OF THE THREE SCREWS, WASHING OF THE FASCIA SUTURE, SUBCUTANEOUS SUTURE AND BACKSTITCHED DERMAL SUTURE WITH PHYSIOLOGICAL SALINE SOLUTION. STERILE DRESSING. POST-OPERATIVE USE OF A THORACIC ABDUCTION ORTHOSIS. THIS PI IS FOR THE 2ND MEDICAL INTERVENTION.

  Patient problems: No Code Available

  MAUDE report 9244165 ↗
• InjuryOct 28, 2019Material Split, Cut or Torn

  THE FOLLOWING EVENT WAS REPORTED: SURGICAL WOUND AND IN-DEPTH PREPARATION, LOCATION AND REMOVAL OF THE OSTEOSYNTHESIS MATERIAL. THE STITCH CERCLAGE MADE AT THE TIME HAS TORN AND IS ALSO REMOVED. LOCATION OF THE SPLINTERED FRAGMENT OF THE TUBERCULUM MAJUS AND CREATION OF A RETRACTION SUTURE. A PDS CORD IS NOW PULLED THROUGH SEVERAL TIMES PROXIMALLY TO THIS STITCH. THE X-RAY CHECK SHOWS THAT THE TUBERCULUM CONGLOMERATE IS HELD SECURELY AND THE SUBACROMIAL SPACE IS FREE. A PROXIMAL HUMERUS PLATE FROM STRYKER IS NOW INSERTED AND SECURED WITH SCREWS. THE AFOREMENTIONED STITCH CERCLAGE AND THE PDS CORD ARE TIED TO THE PLATE. THE X-RAY CHECK SHOWS THE SUPPLY SITUATION AND THE POSITION OF THE PLATE MATERIAL TO BE CORRECT. ANALYSIS OF MOBILITY RESULTS COMPARED TO THE PRE-OPERATIVE FINDINGS, IN WHICH EXTERNAL ROTATION WAS NOT POSSIBLE, NOW SHOWS AN EXTERNAL ROTATION OF 30 DEGREES. THIS PI IS FOR THE 2ND MEDICAL INTERVENTION.

  Patient problems: No Code Available

  MAUDE report 9244163 ↗