MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG UNKNOWN_FRO_PRODUCT; IMPLANT

Catalog Number UNK_FRO

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2014

Event Type  malfunction  

Event Description

While trying to fixate a bsso, the heads of 3 self tapping screws detached.While drilling the final screw, the rainbow drill bit working in detached.Due to unsatisfactory occlusion, the screws were removed and 2.0/2.3 mandible screw were used instead.

Manufacturer Narrative

Device not available for evaluation.If additional information is received it will be reported on a supplemental report.

• Brand Name: UNKNOWN_FRO_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-79 111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-79 111
• Manufacturer Contact: jamshed badarpura ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 3830526
• MDR Text Key: 4450825
• Report Number: 0008010177-2014-00133
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_FRO
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2014
• Initial Date FDA Received: 05/23/2014
• 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 Age: 52 YR